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
Completed · Phase 1
Conditions studied: Healthy
In brief
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 substrate) when administered as multiple doses by collecting the blood samples and conducting the blood tests to measure how much LOXO-305 is in the bloodstream and how the body handles and eliminates LOXO-305 in adult healthy participants. The study will also evaluate the safety and tolerability of LOXO-305. The study will be conducted in two periods. Participants will stay in this study for up to 67 days, including screening.
Key facts
- Study ID
- NCT06215430
- Run by
- Eli Lilly and Company
- People needed
- 16
- Starts
- 2021-01-11
- Expected to finish
- 2021-04-15
- Last updated by the study team
- 2025-03-10
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Covance Clinical Research Unit — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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