A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants
NCT04782076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2024-05-24
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
- Healthy
Interventions
- DRUG
-
Dabigatran
Administered orally.
- DRUG
-
Administered orally.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Loxo Oncology, Inc.
lead INDUSTRY
Principal Investigators
-
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-03-05
- Primary Completion
- 2021-05-17
- Completion
- 2021-05-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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