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NCT02092831 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effect of Formulation and Tablet Hardness on the Bioavailability of Pictilisib in Healthy Volunteers
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02092831: Completed Phase 1 study, sponsored by Genentech.
NCT02092831 is a Phase 1 study that has completed, run by Genentech. 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
NCT02092831, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the relative bioavailability of GDC-0941 administered as a single dose of the market image formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the Phase 2 formulation to healthy male and female volunteers. Participants will be randomly assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation), and GDC-0941 will be administered based on the assigned sequence. The study is expected to last 8 weeks.
Interventions
- DRUG GDC-0941
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT02092831 record still lists
NCT02092831 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 1 intervention - of which GDC-0941 is the first listed.
NCT02092831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02092831 about?
NCT02092831 is a clinical study titled "A Study of the Effect of Formulation and Tablet Hardness on the Bioavailability of Pictilisib in Healthy Volunteers". This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the relative bioavailability of GDC-0941 administered as a single dose of the market image formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the Phase 2 formulation to healthy m...
What is the current status of trial NCT02092831?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-04. Estimated completion is 2014-05.
What interventions are being tested in trial NCT02092831?
The interventions under investigation include: GDC-0941 (DRUG).
Who is sponsoring clinical trial NCT02092831?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02092831'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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