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NCT01953835 · ClinicalTrials.gov registry record · Phase 1
A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT01953835 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 37 participants.
The verdict
NCT01953835, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study is a Phase I, two-part, open-label study designed to evaluate the effect of repeated doses of GSK2586184 on the pharmacokinetics (PK) of Simvastatin and Rosuvastatin in healthy volunteers (Cohort A), and to evaluate the pharmacokinetics of a new tablet formulation of GSK2586184 in healthy male volunteers (Cohort B). Cohort A is a single sequence drug interaction study in which 28 subjects (14 female and 14 male subjects) will be enrolled. Each subject will receive single doses of Simvastatin and Rosuvastatin on two occasions, once alone and once following administration of repeated doses of GSK2586184. Cohort B is a 3-way crossover PK study in which 9 male subjects will be randomized (3 subjects to each treatment sequence). Each subject will receive a single dose of the standard formulation of GSK2586184 with food and two doses of a new formulation of GSK2586184, once with food and once in a fasted state, according to their treatment sequence, with a 3-day wash out between doses. The primary aim of the study is to investigate the effects of GSK2586184 on the pharmacokinetics of the 2 statins and to assess the impact of dosing with and without food on a new formulation of GSK2586184 tablet.
Interventions
- DRUG Rosuvastatin
- DRUG Simvastatin
- DRUG GSK2586184 standard formulation
- DRUG GSK2586184 new formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2013-10-04 |
| Est. Completion | 2014-03-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01953835
The ClinicalTrials.gov registry entry for NCT01953835 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Rosuvastatin is the first listed.
NCT01953835 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01953835 about?
NCT01953835 is a clinical study titled "A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184". This study is a Phase I, two-part, open-label study designed to evaluate the effect of repeated doses of GSK2586184 on the pharmacokinetics (PK) of Simvastatin and Rosuvastatin in healthy volunteers (Cohort A), and to evaluate the pharmacokinetics of a new tablet formulation of GSK2586184 in healthy...
What is the current status of trial NCT01953835?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2013-10-04. Estimated completion is 2014-03-10.
What interventions are being tested in trial NCT01953835?
The interventions under investigation include: Rosuvastatin (DRUG), Simvastatin (DRUG), GSK2586184 standard formulation (DRUG), GSK2586184 new formulation (DRUG).
Who is sponsoring clinical trial NCT01953835?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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