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NCT03796260 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT03796260: Completed Phase 1 study, sponsored by Genentech.
NCT03796260 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03796260, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.
Primary Outcome
The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.
Interventions
- DRUG Entrectinib Test Formulation (F1)
- DRUG Entrectinib Reference Formulation (F06)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-01-09 |
| Est. Completion | 2019-02-04 |
| Phase | Phase 1 |
What the finished NCT03796260 record still lists
NCT03796260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Entrectinib Test Formulation (F1) is the first listed.
NCT03796260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03796260 about?
NCT03796260 is a clinical study titled "A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants". This study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.
What is the current status of trial NCT03796260?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2019-01-09. Estimated completion is 2019-02-04.
What interventions are being tested in trial NCT03796260?
The interventions under investigation include: Entrectinib Test Formulation (F1) (DRUG), Entrectinib Reference Formulation (F06) (DRUG).
Who is sponsoring clinical trial NCT03796260?
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 NCT03796260's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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