Status:
COMPLETED
A Study of Effect of Multiple Doses of LOXO-305 on the Pharmacokinetics of Single Oral Doses of CYP1A2, CYP2C9, CYP2C19 Substrates 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 LOXO-305 on single oral dose of caffeine cytochrome P450 1A2 (CYP1A2) substrate, S-warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 subs...
Eligibility Criteria
Inclusion
- Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m\^2), 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 23-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 :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06215430
Start Date
January 11 2021
End Date
April 15 2021
Last Update
March 10 2025
Active Locations (1)
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1
Covance Clinical Research Unit
Dallas, Texas, United States, 75247