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NCT02536391 · ClinicalTrials.gov registry record · Phase 1
Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects
A Phase 1 study of Cancer, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT02536391 is a Phase 1 study of Cancer that has completed, run by Genentech. The registered enrollment target is 18 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02536391, a Phase 1 study of Cancer, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.
Conditions Studied
Interventions
- DRUG Ipatasertib (capsule)
- DRUG Ipatasertib (tablet)
Study Locations (1)
Wisconsin
- - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-10 |
| Est. Completion | 2015-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02536391
The ClinicalTrials.gov registry entry for NCT02536391 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which Ipatasertib (capsule) is the first listed.
NCT02536391 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT02536391 about?
NCT02536391 is a clinical study titled "Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects". This Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants...
What is the current status of trial NCT02536391?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-10. Estimated completion is 2015-11.
What conditions does trial NCT02536391 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT02536391?
The interventions under investigation include: Ipatasertib (capsule) (DRUG), Ipatasertib (tablet) (DRUG).
Who is sponsoring clinical trial NCT02536391?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02536391 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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