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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Screening visit

- 2021-09-17 - 1 Formulär, 18 Item-grupper, 108 Dataelement, 1 Språk
Item-grupper: Demography, Vital signs, 12-lead ECG, 12-Lead ECG, Abnormality, Holter Electrocardiography, Summary Report, Holter Electrocardiography, Summary Report, Electrocardiogram abnormal, Medical conditions, Physical Examination, History of Tobacco Use, HIV screen, Alcohol consumption, Drug screen, Ethanol measurement, Laboratory Procedures; Chemistry, Clinical, Laboratory Procedures; Haematologic tests, Laboratory Procedures; Urinalysis, Pharmacokinetic aspects, Blood, Inclusion, Exclusion Criteria
Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Study Period

- 2018-12-11 - 1 Formulär, 17 Item-grupper, 85 Dataelement, 1 Språk
Item-grupper: Drug Screen, Ethanol Measurement, Physical Examination, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Laboratory Procedures, Urinalysis, Pharmacokinetic aspects, Blood, Vital signs, 12-Lead-ECG, 12 lead ECG, Abnormality, Randomization, Numbers, Experimental drug, Therapeutic procedure, Confirmation, Pharmacokinetic aspects, Blood, Pharmacokinetic aspects, Blood, Metabolite, Pharmacokinetic aspects, Urine, Pharmacokinetic aspects, Faeces, Entero string test
Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Unscheduled

- 2018-11-06 - 1 Formulär, 5 Item-grupper, 17 Dataelement, 1 Språk
Item-grupper: Vital Signs, 12 lead ECG, Clinical Chemistry, Hematology finding, Urinalysis
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 11

- 2018-11-06 - 1 Formulär, 7 Item-grupper, 26 Dataelement, 1 Språk
Item-grupper: 12-lead ECG, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Capillary Blood Glucose measurement, Pharmacokinetic aspects; Blood
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 4

- 2018-11-06 - 1 Formulär, 7 Item-grupper, 26 Dataelement, 1 Språk
Item-grupper: 12-lead ECG, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Capillary Blood Glucose measurement, Pharmacokinetic aspects; Blood
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 3

- 2018-11-06 - 1 Formulär, 3 Item-grupper, 16 Dataelement, 1 Språk
Item-grupper: 12-lead ECG, Vital Signs, Capillary Blood Glucose measurement
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 10

- 2018-11-06 - 1 Formulär, 3 Item-grupper, 16 Dataelement, 1 Språk
Item-grupper: 12-lead ECG, Vital Signs, Capillary Blood Glucose measurement
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 1

- 2018-11-06 - 1 Formulär, 8 Item-grupper, 32 Dataelement, 1 Språk
Item-grupper: Randomization; Numbers, 12-lead ECG, Electrocardiogram; Telemetry, Vital Signs, Capillary Blood Glucose measurement, Pharmacokinetic aspects; Blood, Experimental drug, Therapeutic procedure; Confirmation
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - 12-lead ECG Abnormalities

- 2018-10-05 - 1 Formulär, 1 Item-grupp, 8 Dataelement, 1 Språk
Item-grupp: 12 lead ECG, Abnormality
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 8

- 2018-10-05 - 1 Formulär, 11 Item-grupper, 40 Dataelement, 1 Språk
Item-grupper: 12-lead ECG, Electrocardiogram; Telemetry, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Capillary Blood Glucose measurement, drug biological activity, Collection of blood specimen for laboratory procedure, Pharmacokinetic aspects; Blood, Experimental drug, Therapeutic procedure; Confirmation
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 2

- 2018-11-06 - 1 Formulär, 13 Item-grupper, 48 Dataelement, 1 Språk
Item-grupper: 12-lead ECG, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Capillary Blood Glucose measurement, Pharmacodynamics, Blood, Glucose, Glucagon, Insulin, C-Peptide, Pharmacodynamics; Blood; Glucagon-Like Peptide 1, drug biological activity, Collection of blood specimen for laboratory procedure, Pharmacokinetic aspects; Blood, Antidiabetics; Tolerability Study, Adverse event, Antidiabetics; Tolerability Study; Worksheet
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 9

- 2018-11-06 - 1 Formulär, 13 Item-grupper, 48 Dataelement, 1 Språk
Item-grupper: 12-lead ECG, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Capillary Blood Glucose measurement, Pharmacodynamics, Blood, Glucose, Glucagon, Insulin, C-Peptide, Pharmacodynamics; Blood; Glucagon-Like Peptide 1, drug biological activity, Collection of blood specimen for laboratory procedure, Pharmacokinetic aspects; Blood, Antidiabetics; Tolerability Study, Adverse event, Antidiabetics; Tolerability Study; Worksheet
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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