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NCT01929876 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01929876: Completed Phase 1 study, sponsored by Genentech.
NCT01929876 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
NCT01929876, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This open-label, 2-period, fixed sequence, drug interaction study will investigate the effect of co-administration of itraconazole on the pharmacokinetics of cobimetinib in healthy participants. Participants will receive multiple repeating doses of cobimetinib and itraconazole.
Primary Outcome
Maximum observed plasma concentration of cobimetinib with and without itraconazole was assessed using a model independent approach.
Interventions
- DRUG Itraconazole
- DRUG Cobimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01929876 record still lists
NCT01929876 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 Itraconazole is the first listed.
NCT01929876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01929876 about?
NCT01929876 is a clinical study titled "A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants". This open-label, 2-period, fixed sequence, drug interaction study will investigate the effect of co-administration of itraconazole on the pharmacokinetics of cobimetinib in healthy participants. Participants will receive multiple repeating doses of cobimetinib and itraconazole.
What is the current status of trial NCT01929876?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01929876?
The interventions under investigation include: Itraconazole (DRUG), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT01929876?
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 NCT01929876'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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