Status:
COMPLETED
A Study of the Effects of Pirtobrutinib (LOXO-305) on Repaglinide (CYP2C8 Substrate) 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 evaluate the effect of pirtobrutinib (LOXO-305) on single oral dose of repaglinide (CYP2C8 substrate) when administered as multiple doses by conducting the blood t...
Eligibility Criteria
Inclusion
- Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
- Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
- Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
- Must have comply with all study procedures, including the 16-night stay at the Clinical Research Unit (CRU) and follow-up phone call
Exclusion
- History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
- Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
Key Trial Info
Start Date :
November 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06165146
Start Date
November 10 2020
End Date
December 30 2020
Last Update
March 17 2025
Active Locations (1)
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1
Covance Clinical Research Unit
Daytona Beach, Florida, United States, 32117