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NCT02045849 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability, Safety, Tolerability, Pharmacokinetics (PK) and Food Effect Study of GSK2140944 in Healthy Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT02045849 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 46 participants.
The verdict
NCT02045849, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
This study will be conducted in three parts (Part 1, Part 2 and Part 3). Part 1 of this study will evaluate the relative bioavailability of a single dose of GSK2140944 tablet formulation compared to the reference capsule formulation under fasted conditions. The effect of food on the pharmacokinetics (PK) of a single dose of the tablet formulation will also be assessed. Part 2 will evaluate the effect of repeat doses of itraconazole on the pharmacokinetics of GSK2140944 following a single dose. A decision will be made whether to use the current capsule formulation or the new tablet formulation in Part 2 based upon the safety and PK data obtained from Part 1. Part 3 is conditionally based upon progression of the tablet formulation from Part 1 and will evaluate the effect of food on the safety, tolerability, and pharmacokinetics of the tablet formulation following multiple doses in elderly healthy subjects.
Interventions
- DRUG GSK2140944 capsule
- DRUG GSK2140944 tablet
- DRUG Itraconazole capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2014-01-28 |
| Est. Completion | 2014-08-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02045849
The ClinicalTrials.gov registry entry for NCT02045849 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 3 interventions - of which GSK2140944 capsule is the first listed.
NCT02045849 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02045849 about?
NCT02045849 is a clinical study titled "Relative Bioavailability, Safety, Tolerability, Pharmacokinetics (PK) and Food Effect Study of GSK2140944 in Healthy Subjects". This study will be conducted in three parts (Part 1, Part 2 and Part 3). Part 1 of this study will evaluate the relative bioavailability of a single dose of GSK2140944 tablet formulation compared to the reference capsule formulation under fasted conditions. The effect of food on the pharmacokinetics...
What is the current status of trial NCT02045849?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2014-01-28. Estimated completion is 2014-08-21.
What interventions are being tested in trial NCT02045849?
The interventions under investigation include: GSK2140944 capsule (DRUG), GSK2140944 tablet (DRUG), Itraconazole capsule (DRUG).
Who is sponsoring clinical trial NCT02045849?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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