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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 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 16 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02063581
The ClinicalTrials.gov registry entry for NCT02063581 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 2 interventions - of which ipatasertib (Capsule) is the first listed.
NCT02063581 reports 0 study locations.
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.
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