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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 21 + Day 22

- 12/27/18 - 1 form, 13 itemgroups, 69 items, 1 language
Itemgroups: Administrative data, Day 21, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Laboratory Test - Urine HCG, Pharmacodynamic Blood Collection, Pharmacokinetic Blood Collection, Day 22, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Pharmacokinetic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 12 (Visit 100): Vital Signs, Pharmacodynamics, Drug Administration

- 12/21/18 - 1 form, 4 itemgroups, 26 items, 1 language
Itemgroups: Administrative data, Study Drug Administration, Vital Signs, Pharmacodynamic Blood Collection
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 38: Vital Signs

- 11/16/18 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 37: Vital Signs

- 11/16/18 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 36: Vital Signs

- 11/16/18 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 29: Vital Signs

- 11/15/18 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 92: Vital Signs

- 11/16/18 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 41: Vital Signs

- 11/16/18 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 1: Vital Signs

- 11/15/18 - 1 form, 3 itemgroups, 19 items, 1 language
Itemgroups: Administrative data, Vital Signs, Randomization
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 2: Vital Signs

- 11/15/18 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Early Term: Vital Signs Form

- 11/19/18 - 1 form, 2 itemgroups, 20 items, 1 language
Itemgroups: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 40: Vital Signs

- 11/16/18 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Vital Signs
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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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