A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants
- Registration Number
- NCT05338489
- Lead Sponsor
- Eli Lilly and Company
- 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 in healthy participants. Information about safety and tolerability will be collected. The study is conducted in two parts and it will last up to 54 days (part 1) and 59 days (part 2), respectively, inclusive of screening period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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 Criteria
- 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- Have previously participated or withdrawn from this study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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Selpercatinib and Itraconazole - Part 1 Period 2 Selpercatinib Selpercatinib and itraconazole administered orally. Selpercatinib - Part 1 Period 1 Selpercatinib Selpercatinib administered orally. Selpercatinib and Itraconazole - Part 1 Period 2 Itraconazole Selpercatinib and itraconazole administered orally. Selpercatinib - Part 2 Period 1 Selpercatinib Selpercatinib administered orally. Selpercatinib and Rifampin - Part 2 Period 2 Selpercatinib Selpercatinib and rifampin administered orally. Selpercatinib and Rifampin - Part 2 Period 2 Rifampin Selpercatinib and rifampin administered orally.
- Primary Outcome Measures
Name Time Method PK: Maximum observed concentration (Cmax) of Selpercatinib Pre-dose up to 168 hour post-dose PK: Cmax of Selpercatinib
PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib Pre-dose up to 168 hour post-dose PK: CL/F of Selpercatinib
PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib Pre-dose up to 168 hour post-dose PK: AUC0-inf of Selpercatinib
Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib Pre-dose up to 168 hour post-dose PK: AUC0-t of Selpercatinib
PK: Time to reach Cmax (Tmax) of Selpercatinib Pre-dose up to 168 hour post-dose PK: Tmax of Selpercatinib
PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib Pre-dose up to 168 hour post-dose PK: AUC%extrap of Selpercatinib
PK: Apparent first-order terminal elimination rate constant (Kel) of Selpercatinib Pre-dose up to 168 hour post-dose PK: Kel of Selpercatinib
PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib Pre-dose up to 168 hour post-dose PK: t½ of Selpercatinib
PK: area under the concentration-time curve, from time 0 to the 24 hours (AUC0-24) of Selpercatinib Day 1 PK: AUC0-24 of Selpercatinib
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States