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NCT02063581 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02063581: Completed Phase 1 study, sponsored by Genentech.
NCT02063581 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02063581, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This Phase I, open-label, randomized, 2-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy adult volunteers. Participants will be randomized to one of two treatment sequences to receive a single oral administration of ipatasertib in tablet or capsule formulation followed, after a washout period, by a single oral administration of ipatasertib in the second formulation. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.
Interventions
- DRUG ipatasertib (Capsule)
- DRUG ipatasertib (Tablet)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT02063581 record still lists
NCT02063581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which ipatasertib (Capsule) is the first listed.
NCT02063581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02063581 about?
NCT02063581 is a clinical study titled "A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers". This Phase I, open-label, randomized, 2-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy adult volunteers. Participants will be randomized to one of two treatment sequences to receive a single oral...
What is the current status of trial NCT02063581?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-02. Estimated completion is 2014-03.
What interventions are being tested in trial NCT02063581?
The interventions under investigation include: ipatasertib (Capsule) (DRUG), ipatasertib (Tablet) (DRUG).
Who is sponsoring clinical trial NCT02063581?
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 NCT02063581's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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