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NCT02390492 · ClinicalTrials.gov registry record · Phase 1
A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02390492 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 8 participants.
The verdict
NCT02390492, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This 2-period, open-label, nonrandomized study will be conducted to determine the absolute bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its metabolite(s). Healthy male participants will receive a single 200-mg oral dose of ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of \[14C\]-ipatasertib. After a 4-day observation period and 10-day washout, participants will receive a single 200-mg/100-mcCi oral dose of \[14C\]-ipatasertib with subsequent data collection for an additional 7 to 14 days until discharge criteria are met.
Interventions
- DRUG Period 1 treatment
- DRUG Period 2 treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02390492
The ClinicalTrials.gov registry entry for NCT02390492 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 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 Period 1 treatment is the first listed.
NCT02390492 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02390492 about?
NCT02390492 is a clinical study titled "A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects". This 2-period, open-label, nonrandomized study will be conducted to determine the absolute bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its metabolite(s). Healthy male participants will receive a single 200-mg oral dose of ipatasertib followed 1 hour later ...
What is the current status of trial NCT02390492?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2015-03. Estimated completion is 2015-04.
What interventions are being tested in trial NCT02390492?
The interventions under investigation include: Period 1 treatment (DRUG), Period 2 treatment (DRUG).
Who is sponsoring clinical trial NCT02390492?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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