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NCT01114607 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01114607: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01114607 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01114607, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is an open-label, single dose, randomized, five-period, crossover study in healthy volunteers to assess the relative bioavailability of four GSK developed oral formulations of GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb, PROTECT-1 Study and ChemoCentryx Thorough QT/QTc Study. Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the five formulations of GSK1605786 after a standard breakfast. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The relative bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx formulation while the relative bioavailability the three other formulations will be compared to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study.
Interventions
- DRUG GSK1605786 ChemoCentryx: formulation A
- DRUG GSK1605786 GSK: formulation B
- DRUG GSK1605786 GSK direct-fill: formulation C
- DRUG GSK1605786 GSK modified-process: formulation D
- DRUG GSK1605786 GSK tablet: formulation E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-05-05 |
| Est. Completion | 2010-06-29 |
| Phase | Phase 1 |
What the finished NCT01114607 record still lists
NCT01114607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which GSK1605786 ChemoCentryx: formulation A is the first listed.
NCT01114607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01114607 about?
NCT01114607 is a clinical study titled "A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects". This is an open-label, single dose, randomized, five-period, crossover study in healthy volunteers to assess the relative bioavailability of four GSK developed oral formulations of GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb, PROTECT-1 Study and ChemoCen...
What is the current status of trial NCT01114607?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-05-05. Estimated completion is 2010-06-29.
What interventions are being tested in trial NCT01114607?
The interventions under investigation include: GSK1605786 ChemoCentryx: formulation A (DRUG), GSK1605786 GSK: formulation B (DRUG), GSK1605786 GSK direct-fill: formulation C (DRUG), GSK1605786 GSK modified-process: formulation D (DRUG), GSK1605786 GSK tablet: formulation E (DRUG).
Who is sponsoring clinical trial NCT01114607?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01114607's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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