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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 4, Cohort 1 Days 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test

- 02/01/2021 - 1 Formulaire, 33 Groupes Item, 122 Eléments de données, 1 Langue
Groupes Item: Date of visit, Investigational Product (Dose) (Part 2 Period 4), ECG, ECG - Day 2 Dose (Part 2 Period 4), ECG - Day 2 Dose (Part 2 Period 4), ECG - Day 3 Dose (Part 2 Period 4), ECG - Day 3 Dose (Part 2 Period 4), ECG - Day 4 Dose (Part 2 Period 4), ECG - Day 4 Dose (Part 2 Period 4), ECG - Day 5 Dose (Part 2 Period 4), ECG - Day 5 Dose (Part 2 Period 4), ECG - Day 6 Dose (Part 2 Period 4), ECG - Day 6 Dose (Part 2 Period 4), Vital Signs - Day 2 Dose (Part 2 Period 4), Vital Signs - Day 2 Dose (Part 2 Period 4), Vital Signs - Day 3 Dose (Part 2 Period 4), Vital Signs - Day 3 Dose (Part 2 Period 4), Vital Signs - Day 4 Dose (Part 2 Period 4), Vital Signs - Day 4 Dose (Part 2 Period 4), Vital Signs - Day 5 Dose (Part 2 Period 4), Vital Signs - Day 5 Dose (Part 2 Period 4), Vital Signs - Day 6 Dose (Part 2 Period 4), Vital Signs - Day 6 Dose (Part 2 Period 4), Pulmonary Function Tests - Day 2 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 2 (Part 2 Period 4), Pulmonary Function Tests - Day 3 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Part 2 Period 4), Pulmonary Function Tests - Day 4 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 4 (Part 2 Period 4), Pulmonary Function Tests - Day 5 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Part 2 Period 4), Pulmonary Function Tests - Day 6 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (Part 2 Period 4)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 4, Cohort 1 Days 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 02/01/2021 - 1 Formulaire, 20 Groupes Item, 72 Eléments de données, 1 Langue
Groupes Item: Date of visit, Investigational Product (Dose) (Part 2 Period 4) , Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4) , Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , ECG (Part 2 Period 4) , ECG (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Summary Holter (Part 2 Period 4) , Summary Holter (Part 2 Period 4) (Pre-Dose - 24 hours), Holter Abnormalities (Part 2 Period 4) , Holter Abnormalities (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 3, Cohort 2: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics; SUmmary Holter; Holter Abnormalities; Pulmonary Function Tests

- 02/01/2021 - 1 Formulaire, 21 Groupes Item, 84 Eléments de données, 1 Langue
Groupes Item: Date of Visit, Local Laboratory - Haematology (Period 3), Local Laboratory - Haematology (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Local Laboratory - Clinical Chemistry (Period 3), Investigational Product (Dose) (Period 3), ECG (Period 3), Vital Signs (Period 3), Local Laboratory - Haematology (24Hr Lab) (Period 3), Local Laboratory - Haematology (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Blood (Period 3), Pharmacokinetics Urine (Period 3), Pharmacokinetics Urine (Period 3), Summary Holter (Period 3), Summary Holter (Period 3) (Pre-Dose - 24 hours), Holter Abnormalities (Period 3), Holter Abnormalities (Period 3), Pulmonary Function Tests (Period 3)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 4, Cohort 2 Days 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test

- 30/12/2020 - 1 Formulaire, 33 Groupes Item, 122 Eléments de données, 1 Langue
Groupes Item: Date of visit, Investigational Product (Dose) (Part 2 Period 4), ECG, ECG - Day 2 Dose (Part 2 Period 4), ECG - Day 2 Dose (Part 2 Period 4), ECG - Day 3 Dose (Part 2 Period 4), ECG - Day 3 Dose (Part 2 Period 4), ECG - Day 4 Dose (Part 2 Period 4), ECG - Day 4 Dose (Part 2 Period 4), ECG - Day 5 Dose (Part 2 Period 4), ECG - Day 5 Dose (Part 2 Period 4), ECG - Day 6 Dose (Part 2 Period 4), ECG - Day 6 Dose (Part 2 Period 4), Vital Signs - Day 2 Dose (Part 2 Period 4), Vital Signs - Day 2 Dose (Part 2 Period 4), Vital Signs - Day 3 Dose (Part 2 Period 4), Vital Signs - Day 3 Dose (Part 2 Period 4), Vital Signs - Day 4 Dose (Part 2 Period 4), Vital Signs - Day 4 Dose (Part 2 Period 4), Vital Signs - Day 5 Dose (Part 2 Period 4), Vital Signs - Day 5 Dose (Part 2 Period 4), Vital Signs - Day 6 Dose (Part 2 Period 4), Vital Signs - Day 6 Dose (Part 2 Period 4), Pulmonary Function Tests - Day 2 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 2 (Part 2 Period 4), Pulmonary Function Tests - Day 3 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Part 2 Period 4), Pulmonary Function Tests - Day 4 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 4 (Part 2 Period 4), Pulmonary Function Tests - Day 5 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Part 2 Period 4), Pulmonary Function Tests - Day 6 Dose (Part 2 Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (Part 2 Period 4)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 4, Cohort 2 Days 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 30/12/2020 - 1 Formulaire, 20 Groupes Item, 72 Eléments de données, 1 Langue
Groupes Item: Date of visit, Investigational Product (Dose) (Part 2 Period 4) , ECG (Part 2 Period 4) , ECG (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4) , Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4) , Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Summary Holter (Part 2 Period 4) , Summary Holter (Part 2 Period 4) (Pre-Dose - 24 hours), Holter Abnormalities (Part 2 Period 4) , Holter Abnormalities (Part 2 Period 4)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 5, Cohort 2: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics; SUmmary Holter; Holter Abnormalities; Pulmonary Function Tests

- 30/12/2020 - 1 Formulaire, 21 Groupes Item, 84 Eléments de données, 1 Langue
Groupes Item: Date of Visit, Local Laboratory - Haematology (Period 5), Local Laboratory - Haematology (Period 5), Local Laboratory - Clinical Chemistry (Period 5), Local Laboratory - Clinical Chemistry (Period 5), Investigational Product (Dose) (Period 5), ECG (Period 5), Vital Signs (Period 5), Local Laboratory - Haematology (24Hr Lab) (Period 5), Local Laboratory - Haematology (24 Hr Lab) (Period 5), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 5), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 5), Pharmacokinetics Blood (Period 5), Pharmacokinetics Blood (Period 5), Pharmacokinetics Urine (Period 5), Pharmacokinetics Urine (Period 5), Summary Holter (Period 5), Summary Holter (Period 5) (Pre-Dose - 24 hours) , Holter Abnormalities (Period 5), Holter Abnormalities (Period 5), Pulmonary Function Tests (Period 5)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 6, Cohort 2 Day 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 30/12/2020 - 1 Formulaire, 20 Groupes Item, 72 Eléments de données, 1 Langue
Groupes Item: Date of visit, Investigational Product (Dose) (Period 6), ECG (Period 6), ECG (Period 6), Vital Signs (Period 6), Vital Signs (Period 6), Pulmonary Function Tests (Period 6), Pulmonary Function Tests (Period 6), Local Laboratory - Haematology (24Hr Lab) (Period 6) , Local Laboratory - Haematology (24 Hr Lab) (Period 6), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 6), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 6) , Pharmacokinetics Blood (Period 6), Pharmacokinetics Blood (Period 6), Pharmacokinetics Urine (Period 6), Pharmacokinetics Urine (Period 6), Summary Holter (Period 6), Summary Holter (Period 6) (Pre-Dose - 24 hours), Holter Abnormalities, Holter Abnormalities
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 6, Cohort 2 Day 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test

- 30/12/2020 - 1 Formulaire, 33 Groupes Item, 122 Eléments de données, 1 Langue
Groupes Item: Date of visit, Investigational Product (Dose) (Period 6), ECG, ECG - Day 2 Dose (Period 6), ECG - Day 2 Dose (Period 6), ECG - Day 3 Dose (Period 6) , ECG - Day 3 Dose (Period 6) , ECG - Day 4 Dose (Period 6) , ECG - Day 4 Dose (Period 6) , ECG - Day 5 Dose (Period 6), ECG - Day 5 Dose (Period 6), ECG - Day 6 Dose (Period 6), ECG - Day 6 Dose (Period 6), Vital Signs - Day 2 Dose (Period 6), Vital Signs - Day 2 Dose (Period 6), Vital Signs - Day 3 Dose (Period 6), Vital Signs - Day 3 Dose (Period 6) , Vital Signs - Day 4 Dose (Period 6) , Vital Signs - Day 4 Dose (Period 6) , Vital Signs - Day 5 Dose (Period 6), Vital Signs - Day 5 Dose (Period 6) , Vital Signs - Day 6 Dose (Period 6), Vital Signs - Day 6 Dose (Period 4), Pulmonary Function Tests - Day 2 Dose (Period 6), Pulmonary Function Tests - 2 hours Post-Dose, Day 2 (Period 6), Pulmonary Function Tests - Day 3 Dose (Period 6), Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Period 6), Pulmonary Function Tests - Day 4 Dose (Period 6), Pulmonary Function Tests - 2 hours Post-Dose, Day 4 (Period 6) , Pulmonary Function Tests - Day 5 Dose (Period 6), Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Period 6) , Pulmonary Function Tests - Day 6 Dose (Period 6) , Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (Period 6)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 1, Period 4, Day 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 29/12/2020 - 1 Formulaire, 20 Groupes Item, 72 Eléments de données, 1 Langue
Groupes Item: Date of visit, Investigational Product (Dose) (Period 4) , ECG (Period 4), ECG (Period 4) , Vital Signs (Period 4), Vital Signs (Period 4) , Pulmonary Function Tests (Period 4), Pulmonary Function Tests (Period 4) , Local Laboratory - Haematology (24Hr Lab) (Period 4) , Local Laboratory - Haematology (24 Hr Lab) (Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4) , Pharmacokinetics Blood (Period 4), Pharmacokinetics Blood (Period 4) , Pharmacokinetics Urine (Period 4), Pharmacokinetics Urine (Period 4), Summary Holter (Period 4), Summary Holter (Period 4) (Pre-Dose - 24 hours), Holter Abnormalities, Holter Abnormalities
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 1, Period 4, Days 2-6: Investigational Product; ECG; Vital Signs; Pulmonary Function Test

- 28/12/2020 - 1 Formulaire, 33 Groupes Item, 122 Eléments de données, 1 Langue
Groupes Item: Date of visit, Investigational Product (Dose) (Period 4), ECG, ECG - Day 2 Dose (Period 4) , ECG - Day 2 Dose (Period 4) , ECG - Day 3 Dose (Period 4) , ECG - Day 3 Dose (Period 4) , ECG - Day 4 Dose (Period 4) , ECG - Day 4 Dose (Period 4) , ECG - Day 5 Dose (Period 4), ECG - Day 5 Dose (Period 4), ECG - Day 6 Dose (Period 4) , ECG - Day 6 Dose (Period 4) , Vital Signs - Day 2 Dose (Period 4), Vital Signs - Day 2 Dose (Period 4) , Vital Signs - Day 3 Dose (Period 4) , Vital Signs - Day 3 Dose (Period 4) , Vital Signs - Day 4 Dose (Period 4) , Vital Signs - Day 4 Dose (Period 4) , Vital Signs - Day 5 Dose (Period 4), Vital Signs - Day 5 Dose (Period 4) , Vital Signs - Day 6 Dose (Period 4) , Vital Signs - Day 6 Dose (Period 4), Pulmonary Function Tests - Day 2 Dose (Period 4) , Pulmonary Function Tests - 2 hours Post-Dose, Day 2 (Period 4), Pulmonary Function Tests - Day 3 Dose (Period 4) , Pulmonary Function Tests - 2 hours Post-Dose, Day 3 (Period 4) , Pulmonary Function Tests - Day 4 Dose (Period 4), Pulmonary Function Tests - 2 hours Post-Dose, Day 4 (Period 4) , Pulmonary Function Tests - Day 5 Dose (Period 4) , Pulmonary Function Tests - 2 hours Post-Dose, Day 5 (Period 4) , Pulmonary Function Tests - Day 6 Dose (Period 4) , Pulmonary Function Tests - 2 hours Post-Dose, Day 6 (Period 4)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 1, Period 4, Day 1: Local Laboratory; Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Holter Summary; Holter Abnormalities

- 22/12/2020 - 1 Formulaire, 20 Groupes Item, 75 Eléments de données, 1 Langue
Groupes Item: Date of visit, Local Laboratory - Haematology (Period 4), Local Laboratory - Haematology (Period 4) , Local Laboratory - Clinical Chemistry (Period 4) , Local Laboratory - Clinical Chemistry (Period 4) , Investigational Product (Dose) (Period 4) , ECG (Period 4), ECG (Period 4) , Vital Signs (Period 4), Vital Signs (Period 4) , Pulmonary Function Tests (Period 4), Pulmonary Function Tests (Period 4) , Local Laboratory - Haematology (24Hr Lab) (Period 4) , Local Laboratory - Haematology (24 Hr Lab) (Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4) , Summary Holter (Period 4), Summary Holter (Period 4) (Pre-Dose - 24 hours), Holter Abnormalities, Holter Abnormalities
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 1, Period 1 - 3: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics

- 22/12/2020 - 1 Formulaire, 17 Groupes Item, 61 Eléments de données, 1 Langue
Groupes Item: Date of Visit, Local Laboratory - Haematology (Period 1 - 3), Local Laboratory - Haematology (Period 1 - 3), Local Laboratory - Clinical Chemistry (Period 1 - 3), Local Laboratory - Clinical Chemistry (Period 1 - 3), Investigational Product (Dose) (Period 1 - 3), ECG (Period 1 - 3), Vital Signs (Period 1 - 3), Pulmonary Function Tests (Period 1 - 3), Local Laboratory - Haematology (24Hr Lab) (Period 1 - 3), Local Laboratory - Haematology (24 Hr Lab) (Period 1 - 3) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3) , Pharmacokinetics Blood (Period 1 - 3), Pharmacokinetics Blood (Period 1 - 3), Pharmacokinetics Urine (Period 1 - 3), Pharmacokinetics Urine (Period 1 - 3)
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

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