Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 24 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02092831
The ClinicalTrials.gov registry entry for NCT02092831 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 Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GDC-0941 is the first listed.
NCT02092831 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.