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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis)

- 15-05-20 - 1 Formulier, 5 Itemgroepen, 50 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Local Laboratory Result Data - Clinical Chemistry, Laboratory result data - Haematology, Urinalysis (Dipstick) Test, Urinalysis (Microscopy) Test
Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Local Laboratory Result Data (Clinical Chemistry, Haematology, Urinalysis) Form has to be filled in at following visits: Screening, Treatment Period 1 Predose, Treatment Period 1 Prior to Discharge, Treatment Period 2 Predose, Treatment Period 2 Prior to Discharge, and whenever further assesments are done during the study (Unscheduled).

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 10-10-17 - 1 Formulier, 18 Itemgroepen, 72 Data-elementen, 1 Taal
Itemgroepen: Concomitant medication, Adverse event, Patient diary, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test, Physical examination, Hematology Laboratory evaluation, Hematology Laboratory evaluation, Serum Laboratory evaluation, Serum laboratory evaluation, Urinalysis, Dip stick analysis, Microscopic analysis, Overall urinalysis assessment, Study Completion Part A, Study Completion Part B, Investigator signature
Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194) - Week 8

- 06-03-19 - 1 Formulier, 10 Itemgroepen, 17 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Experimental drug, Medication Summary, Restless Legs Syndrome, Score, Questionnaires; Restless Legs Syndrome; patient assessment, Vital signs, Medical procedure, Concomitant Agent, Adverse Event, Laboratory Procedures, Evaluation, Urine dipstick test
Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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

- 06-11-18 - 1 Formulier, 13 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: 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

- 06-11-18 - 1 Formulier, 13 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: 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 -2

- 06-11-18 - 1 Formulier, 3 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Vital Signs, Urine drug screening, Ethanol measurement, Urine; Ethanol measurement, breath
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 - Screening

- 06-11-18 - 1 Formulier, 14 Itemgroepen, 67 Data-elementen, 1 Taal
Itemgroepen: Demography, Childbearing Potential, Physical Examination, Medical Conditions, Vital Signs, 12-lead ECG, Holter Electrocardiography, Clinical Chemistry, Hematology finding, Urinalysis, Immunogenicity Study; Blood, Urine drug screening, Ethanol measurement, Urine; Ethanol measurement, breath, HIV Seropositivity, hepatitis b serology, hepatitis C serology test
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 - Final Follow-Up

- 09-10-18 - 1 Formulier, 9 Itemgroepen, 30 Data-elementen, 1 Taal
Itemgroepen: 12-lead ECG, Vital Signs, Physical Examination, Clinical Chemistry, Hematology finding, Urinalysis, Fructosamine measurement, Immunogenicity Study; Blood, 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 13

- 09-10-18 - 1 Formulier, 14 Itemgroepen, 51 Data-elementen, 1 Taal
Itemgroepen: 12-lead ECG, Vital Signs, Physical Examination, Clinical Chemistry, Hematology finding, Urinalysis, Free Fatty Acids measurement, Fructosamine measurement, Capillary Blood Glucose measurement, 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 -1

- 09-10-18 - 1 Formulier, 16 Itemgroepen, 59 Data-elementen, 1 Taal
Itemgroepen: 12-lead ECG, Vital Signs, Clinical Chemistry, Hematology finding, Urinalysis, Free Fatty Acids measurement, Fructosamine measurement, Urine pregnancy test, 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

- 08-10-18 - 1 Formulier, 13 Itemgroepen, 47 Data-elementen, 1 Taal
Itemgroepen: 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

- 08-10-18 - 1 Formulier, 13 Itemgroepen, 47 Data-elementen, 1 Taal
Itemgroepen: 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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