Trials / Completed
CompletedNCT03796013
A Study to Investigate the Bioequivalence of Two Different Forms of Entrectinib (Forms A and C) Under Fasted Conditions in Healthy Subjects
A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Way Crossover Study to Investigate the Bioequivalence of Entrectinib Polymorph Forms A and C Under Fasted Conditions in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
This study aims to demonstrate similarities between two different forms of entrectinib (A and C) when administered under fasted conditions in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entrectinib Form A | Participants will receive a single oral dose of entrectinib form A under fasted conditions. |
| DRUG | Entrectinib Form C | Participants will receive a single oral dose of entrectinib form C under fasted conditions. |
Timeline
- Start date
- 2019-01-10
- Primary completion
- 2019-02-06
- Completion
- 2019-02-06
- First posted
- 2019-01-08
- Last updated
- 2020-03-09
- Results posted
- 2020-03-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03796013. Inclusion in this directory is not an endorsement.