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NCT02300025 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02300025 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 28 participants.
The verdict
NCT02300025, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study is an open-label, multi-center, single-dose, parallel group study to determine the pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted male and female adult subjects with varying degrees of hepatic function. The study will be conducted based on the Child-Pugh classification of hepatic impairment. The anticipated duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers with varying degrees of hepatic function and up to 12 healthy control volunteers.
Interventions
- DRUG cobimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02300025
The ClinicalTrials.gov registry entry for NCT02300025 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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 1 intervention - of which cobimetinib is the first listed.
NCT02300025 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02300025 about?
NCT02300025 is a clinical study titled "A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage". This study is an open-label, multi-center, single-dose, parallel group study to determine the pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted male and female adult subjects with varying degrees of hepatic function. The study will be conducted based on the Ch...
What is the current status of trial NCT02300025?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2014-08. Estimated completion is 2015-01.
What interventions are being tested in trial NCT02300025?
The interventions under investigation include: cobimetinib (DRUG).
Who is sponsoring clinical trial NCT02300025?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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