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NCT03222310 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03222310: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03222310 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03222310, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug interaction study in healthy subjects. The primary purpose of this study is to evaluate the effect of itraconazole on the PK of ipatasertib and its primary metabolite (G-037720).
Primary Outcome
Cmax is the maximum observed concentration.
Interventions
- DRUG Ipatasertib
- DRUG Itraconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-07-18 |
| Est. Completion | 2017-09-06 |
| Phase | Phase 1 |
What the finished NCT03222310 record still lists
NCT03222310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Ipatasertib is the first listed.
NCT03222310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03222310 about?
NCT03222310 is a clinical study titled "A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib". This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug interaction study in healthy subjects. The primary purpose of this study is to evaluate the effect of itraconazole on the PK of ipatasertib and its primary metabolite (G-037720).
What is the current status of trial NCT03222310?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-07-18. Estimated completion is 2017-09-06.
What interventions are being tested in trial NCT03222310?
The interventions under investigation include: Ipatasertib (DRUG), Itraconazole (DRUG).
Who is sponsoring clinical trial NCT03222310?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03222310's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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