A Study of the Effects of Pirtobrutinib (LOXO-305) on Repaglinide (CYP2C8 Substrate) in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy
In brief
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 tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib (LOXO-305) in adult healthy participants. The study will also evaluate the safety and tolerability of pirtobrutinib (LOXO-305). The study is conducted in two periods. Participants will stay in this study for up to 54 days.
Key facts
- Study ID
- NCT06165146
- Run by
- Eli Lilly and Company
- People needed
- 16
- Starts
- 2020-11-10
- Expected to finish
- 2020-12-30
- Last updated by the study team
- 2025-03-17
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/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
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 — Daytona Beach, Florida, United States
Full record on ClinicalTrials.gov
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