Trials / Completed
CompletedNCT04782076
A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants
An Open-Label Study to Investigate the Effect of Selpercatinib on the Pharmacokinetics of Dabigatran in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Loxo Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The main purpose of this study is to determine the effect of selpercatinib on the levels of dabigatran in the blood stream and how long it takes the body to remove dabigatran. This study will also look at how safe and well-tolerated of dabigatran when administered in combination with selpercatinib in healthy participants. This study will last approximately 22 to 25 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dabigatran | Administered orally. |
| DRUG | Selpercatinib | Administered orally. |
Timeline
- Start date
- 2021-03-05
- Primary completion
- 2021-05-17
- Completion
- 2021-05-17
- First posted
- 2021-03-04
- Last updated
- 2024-05-24
- Results posted
- 2024-05-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04782076. Inclusion in this directory is not an endorsement.