Trials / Completed
CompletedNCT03222310
A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib
Effect of a Potent CYP3A and P-gp Inhibitor (Itraconazole) on Ipatasertib Pharmacokinetics in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ipatasertib | Ipatasertib 100 mg tablet orally once daily. |
| DRUG | Itraconazole | Itraconazole 100 mg capsules orally once daily. |
Timeline
- Start date
- 2017-07-18
- Primary completion
- 2017-09-06
- Completion
- 2017-09-06
- First posted
- 2017-07-19
- Last updated
- 2017-11-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03222310. Inclusion in this directory is not an endorsement.