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NCT00996268 · ClinicalTrials.gov registry record · Phase 1
An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836.
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT00996268 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 46 participants.
The verdict
NCT00996268, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
Sixteen healthy subjects will be randomized to each of the 3 parallel treatment groups. Eligible subjects will check in to the clinical unit on Day -2 and have 24-hr pharmacokinetic collections on Day -1 and on Day 1. Once the pharmacokinetic parameters of the formulations have been analyzed, doses of GSK2212836 will be selected for further study in Part B. Subjects from Part A will participate in Part B. Part B is a single blind, randomized, placebo controlled study that will consist of a 2-week repeat dose period with 3 dose levels and one dose of the marketed formulation of GSK2212836. Subjects will check in to the clinical unit on Day -3; will participate in a test meal on Day -2 and have 24-hr baseline pharmacokinetic profiles on Day -1 and Day 1. Subjects will be released from the clinic on Day 2, and return for daily dosing on Days 3 through 12. On Day 6, they will also have a brief outpatient visit. Subjects will check into the clinic again on the evening of Day 12, and on Day 13 they will again have 24-hr pharmacokinetic profiles collected. Subjects will be released from the clinical research unit on Day 14, following a test meal, triglyceride sampling and check-out assessments, and will be released from the study 5-10 days later after completing a follow up visit.
Interventions
- DRUG GSK2212836
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2009-10-15 |
| Est. Completion | 2010-01-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00996268
The ClinicalTrials.gov registry entry for NCT00996268 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 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 1 intervention - of which GSK2212836 is the first listed.
NCT00996268 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00996268 about?
NCT00996268 is a clinical study titled "An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836.". Sixteen healthy subjects will be randomized to each of the 3 parallel treatment groups. Eligible subjects will check in to the clinical unit on Day -2 and have 24-hr pharmacokinetic collections on Day -1 and on Day 1. Once the pharmacokinetic parameters of the formulations have been analyzed, doses ...
What is the current status of trial NCT00996268?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2009-10-15. Estimated completion is 2010-01-04.
What interventions are being tested in trial NCT00996268?
The interventions under investigation include: GSK2212836 (DRUG).
Who is sponsoring clinical trial NCT00996268?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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