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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: Completed Phase 1 study of Cancer, sponsored by Genentech.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02536391 record still lists
NCT02536391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02536391's enrollment target sits among peer trials
18 572nd of 615 higher than 43 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer 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.
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