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Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Pharmacokinetics Blood (Period 1 - 5; Day 1 - Day 16)

- 06/11/2019 - 1 Formulaire, 6 Groupes Item, 11 Eléments de données, 1 Langue
Groupes Item: Pharmacokinetics Blood - Dosing date and time (Period 1 - 5), Repeat Pharmacokinetics Blood (Period 1 - 5), Pharmacokinetics Blood - Dosing date and time (Day 1 - 13), Reeat Pharmacokinetics Blood (Day 1 - 13) , Pharmacokinetics Blood - Dosing date and time (Day 14 - 16), Pharmacokinetics Blood (Day 14 - 16)
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Nasal Endoscopy (Period 1 -5; Day 1 - Day 16)

- 06/11/2019 - 1 Formulaire, 3 Groupes Item, 45 Eléments de données, 1 Langue
Groupes Item: Visual Nasal Endoscopy (Period 1 - 5), Nasal Endoscopy (Day 1 - 13), Nasal Endoscopy (Day 14 - 16)
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Visual Nasal Examination (Period 1 - 5; Day 1 - Day 16)

- 06/11/2019 - 1 Formulaire, 3 Groupes Item, 45 Eléments de données, 1 Langue
Groupes Item: Repeat Visual Nasal Endoscopy (Period 1 - 5), Repeat Visual Nasal Endoscopy (Day 1 - 13) , Repeat Visual Nasal Endoscopy (Day 14 - 16)
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Visual Analogue Scale (Period 1 - 5; Day 1 - Day 16)

- 06/11/2019 - 1 Formulaire, 5 Groupes Item, 53 Eléments de données, 1 Langue
Groupes Item: Visual Analogue Scale - Dosing Date and Time (Period 1 - 5) , Visual Analogue Scale (Period 1 - 5), Visual Analogue Scale (Day 3 - Day 13), Visual Analogue Scale - Dosing date/ time (Day 14 - 16), Visual Analogue Scale (Day 14 - 16)
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Vital Signs (Period 1 - 5; Day 1 - Day 13)

- 05/11/2019 - 1 Formulaire, 4 Groupes Item, 15 Eléments de données, 1 Langue
Groupes Item: Vital Signs (Period 1 - 5) - Dosing date/ time, Vital Signs (Period 1 -5), Vital Signs (Day 1 - 13) - Dosing date/ time, Vital Signs (Day 1 - 13)
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - 12-Lead ECG (Period 1 -5; Day 1 - Day 13)

- 05/11/2019 - 1 Formulaire, 4 Groupes Item, 19 Eléments de données, 1 Langue
Groupes Item: 12-Lead ECG (Period 1 - 5) - Dosing date/time, 12-Lead ECG (Period 1 - 5), 12-Lead ECG (Day 1 - 13) - Dose, 12-Lead ECG (Day 1 - 13)
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Investigational Product (Period 1 - 5; Day 1 - Day 16)

- 05/11/2019 - 1 Formulaire, 4 Groupes Item, 19 Eléments de données, 1 Langue
Groupes Item: Investigational Product (Dose) (Period 1 - 5), Investigational Product (Dose) (Day 1 - 13), Investigational Product (Day 3 - Day 13 Dose), Investigational Product (Dose) (Day 14 - 16)
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Electronically Transferred Lab Data (Period 1 - 5; Day 1 - Day 16)

- 01/11/2019 - 1 Formulaire, 8 Groupes Item, 67 Eléments de données, 1 Langue
Groupes Item: Electronically Transferred Lab Data (Day-1 Labs) (Period 1-5), Electronically Transferred Lab Data (Day-1 Labs (steroid hormone test)) (Period 1-5), Electronically Transferred Lab Data (Lab), Electronically Transferred Lab Data (Lab (steroid hormone test)) (Period 1-5), Electronically Transferred Lab Data (Lab) (Day 1 - 13), Electronicallly Transferred Lab Data (Lab (steroid hormone test)) (Day 1 - 13), Electronically Transferred Lab Data (Lab) (Day 14 - 16), Electronically Transferred Lab Data (Lab (steroid hormone test)) (Day 14 - 16)
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Liver Event - Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Medical Conditions; Alcohol Intake (Liver Alcohol); Liver Imaging; Liver Biopsy

- 31/10/2019 - 1 Formulaire, 10 Groupes Item, 102 Eléments de données, 1 Langue
Groupes Item: Liver Events, Investigational Product (Liver), Pharmacokinetics (Liver PK), Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake, Liver imaging, Liver Biopsy
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Pharmacogenetic Research Consent; Pharmacogenetic Research Withdrawal of Consent

- 31/10/2019 - 1 Formulaire, 2 Groupes Item, 11 Eléments de données, 1 Langue
Groupes Item: Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Repeating Logs

- 30/10/2019 - 1 Formulaire, 8 Groupes Item, 70 Eléments de données, 1 Langue
Groupes Item: Administrative data, Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions), NON-SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, RELEVANT CONCOMITANT/TREATMENT MEDICATIONS, RELEVANT MEDICAL CONDITION/RISK FACTORS, 12-lead/Holter/Telemetry ECG, CONCOMITANT MEDICATION
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Logs/ Repeats - 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood; Repeat Visual Analogue Scale; Repeat Nasal Endoscopy; Repeat Visual Nasal Examination

- 29/10/2019 - 1 Formulaire, 5 Groupes Item, 51 Eléments de données, 1 Langue
Groupes Item: 12-Lead ECG, 12-Lead ECG Abnormalities, Repeat Pharmacokinetics Blood, Repeat Visual Analogue Scale, Repeat Visual Nasal Endoscopy
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

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