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  1. 1. Clinical Trial
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - Pharmacogenetic research consent and withdrawal of consent

- 10/11/19 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: Administrative Data, PGx - Pharmacogenetic research consent, Pharmacogenetic research withdrawal of consent
Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the Pharmacogenetic research consent and withdrawal of consent form.

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - PGx - Pharmacogenetic Research Consent

- 9/17/19 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Pharmacogenetic Test, Informed Consent
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female 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: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - PGx - Pharmacogenetic Research Withdrawal of Consent

- 9/17/19 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: Pharmacogenetic Test, Informed Consent, Withdraw
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female 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: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377) - Pharmacogenetics - Research Consent; Research Withdrawal of Consent

- 8/16/19 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent
Study ID: 105377 Clinical Study ID: 105377 Study Title: A randomised, open-label, parallel-group design study to evaluate the pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Epilepsy

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Pharmacogenetics - Research Consent; Research Withdrawal of Consent

- 8/4/19 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Death; Study Conclusion; Pharmacogenetic Research Withdrawal of Consent; Pregnancy Information; Investigatoinal Product Discontinuation; Investigational Product Compliance - Pazopanib; Log Status

- 5/23/19 - 1 form, 7 itemgroups, 26 items, 1 language
Itemgroups: Death, Study Conclusion, Pharmacogenetic Research Withdrawal of Consent, Pregnancy Information, Investigational Product Discontinuation, Investigational Product Compliance, Log Status
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Day 1 Pre-Dose -Vital Signs; Pharmacogenetic Research Consent/ Blood Sample Collection; Investigational Product Compliance (Pazopanib); Investigational Product (First Dose); Biomarker Samples

- 5/16/19 - 1 form, 6 itemgroups, 30 items, 1 language
Itemgroups: Date of visit/ assessment, Vital Signs, Pharmacogenetic Research Consent/ Blood Sample Collection, Investigational Product Compliance - Pazopanib, Investigational Product - First Dose, Biomarker Sample
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Pharmacogenetics - Pharmacogenetic Research Consent; Pharmacogenetics Research Withdrawal of Consent

- 5/6/19 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Pharmacogenetic Research Consent, Withdrawal of consent for PGx (DNA) sample destruction
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963 - PGx-Pharmacogenetic Research

- 4/22/19 - 1 form, 5 itemgroups, 9 items, 1 language
Itemgroups: Administrative documentation, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, DNA, Pharmacogenetic Test, Informed Consent, Withdraw, Pharmacogenetic Test, Blood specimen, Destruction
Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male 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: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

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

- 3/13/19 - 1 form, 4 itemgroups, 15 items, 1 language
Itemgroups: Administrative data, Pharmacogenetic (PGx) Research Consent, PGx-Pharmacogenetic Research Consent Withdrawal, Investigator's Signature
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

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - PGx - Pharmacogenetic Research

- 2/25/19 - 1 form, 5 itemgroups, 9 items, 1 language
Itemgroups: Administrative documentation, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Collection of Blood Specimen for Laboratory Procedure, Pharmacogenetic Test, Informed Consent, Withdraw, Pharmacogenetic Test, Blood Specimen, Destruction
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888 - PGx-Pharmacogenetic research

- 2/1/19 - 1 form, 5 itemgroups, 12 items, 1 language
Itemgroups: Administrative data, PGx-Pharmacogenetic research consent, Blood sample collection, Withdrawal of consent, Blood sample destruction
Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female 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: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the PGx-Pharmacogenetic research form. It has to be filled in for the end of study.

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