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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Early Term Data: Vital Signs, Physical Examination, ECG, Laboratory Tests

- 28/12/18 - 1 formulario, 9 itemgroups, 55 items, 1 idioma

Itemgroups: Administrative data, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Physical Examination, Electrocardiogram, Overall Interpretation of ECG, Hematologic Test, Chemistry Test, UA / Urine Chemistry Test

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 - Follow-Up: Vital Signs, Electrocardiogram, Laboratory Tests

- 28/12/18 - 1 formulario, 9 itemgroups, 56 items, 1 idioma

Itemgroups: Administrative data, Vital Signs - Duplicate 1, Duplicate 2, Physical Examination, Electrocardiogram, Overall Interpretation of ECG, Hematologic Test, Chemistry Test, UA / Urine Chemistry Test

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 2 Day 21 + Day 22

- 27/12/18 - 1 formulario, 13 itemgroups, 69 items, 1 idioma

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 2 Day 18 + Day 19 + Day 20

- 27/12/18 - 1 formulario, 21 itemgroups, 112 items, 1 idioma

Itemgroups: Administrative data, Day 18, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Day 19, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Study Drug Administration 2 , Pharmacokinetic Blood Collection, Day 20, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Electrocardiogram, Overall Interpretation of ECG, Study Drug Administration, Hematologic Test, Chemistry Test, UA/Urine Chemistry, 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 2 Day 13 + Day 14

- 27/12/18 - 1 formulario, 13 itemgroups, 72 items, 1 idioma

Itemgroups: Administrative data, Day 13, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Pharmacodynamic Blood Collection, Day 14, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Electrocardiogram, Overall Interpretation of ECG, Study Drug Administration, 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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 11 + Day 12

- 27/12/18 - 1 formulario, 12 itemgroups, 68 items, 1 idioma

Itemgroups: Administrative data, Day 11, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Pharmacodynamic Blood Collection, Day 12, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Study Drug Administration 2 , 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

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 2 Day 1 + Day 5

- 27/12/18 - 1 formulario, 15 itemgroups, 80 items, 1 idioma

Itemgroups: Administrative data, Day 1, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Hematology Test, Chemistry, UA / UDS / Urine HCG / Urine Chemistry, Pharmacodynamic Blood Collection, Pharmacodynamic Blood Collection 2, Day 5, Vital Signs - Duplicate 1, Vital Signs - Duplicate 2, Study Drug Administration, Study Drug Administration 2

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 22+26 (Visit 160-170): Vital Signs, Drug Administration, ECG, Laboratory Tests

- 24/12/18 - 1 formulario, 11 itemgroups, 57 items, 1 idioma

Itemgroups: Administrative data, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration, Pharmacokinetic Blood Collection, Period 1 - Day 26, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration

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 20-21 (Visit 140-150): Vital Signs, Drug Administration, ECG, Laboratory Tests

- 24/12/18 - 1 formulario, 18 itemgroups, 91 items, 1 idioma

Itemgroups: Administrative data, Vital Signs, Duplicate 1, Duplicate 2, Study Drug Administration, Hematology Test, Chemistry Test, UA / Urine Chemistry Test, Pharmacokinetic Blood Collection, Period 1 - Day 21, Vital Signs, Duplicate 1, Duplicate 2, Electrocardiogram, Overall Interpretation of ECG, Study Drug Administration, Pharmacodynamic Blood Connection, Pharmacokinetic Blood Collection 12 hr span

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 19 (Visit 130): Pharmacokinetics, Vital Signs, Drug Administration9

- 21/12/18 - 1 formulario, 4 itemgroups, 27 items, 1 idioma

Itemgroups: Administrative data, Study Drug Administration, Vital Signs, 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 13 (Visit 110): Pharmacodynamics, Vital Signs, Drug Administration

- 21/12/18 - 1 formulario, 4 itemgroups, 28 items, 1 idioma

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

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Blood Sampling for Lamotrigine or PK and Metabolites

- 21/12/18 - 1 formulario, 2 itemgroups, 16 items, 1 idioma

Itemgroups: Administrative Data, Blood Sample for PK and metabolites or Lamotrigine

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about the blood sampling for lamotrigine or pharmakokinetics and metabolites. It should be filled out at each treatment period. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

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