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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 24 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01114607
The ClinicalTrials.gov registry entry for NCT01114607 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 5 interventions - of which GSK1605786 ChemoCentryx: formulation A is the first listed.
NCT01114607 reports 0 study locations.
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.
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