Status:
COMPLETED
A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Loxo Oncology, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to assess the effect of itraconazole and rifampin on how fast selpercatinib gets into the blood stream and how long it takes the body to remove it when administered i...
Eligibility Criteria
Inclusion
- Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
Exclusion
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
- Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2
Key Trial Info
Start Date :
May 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05338489
Start Date
May 11 2018
End Date
August 22 2018
Last Update
September 19 2025
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283