A Study of Effects of Selpercatinib (LY3527723) on Midazolam in Healthy Participants
- Registration Number
- NCT05338476
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to assess the effect of selpercatinib on how fast midazolam 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 will last up to about 6 weeks, inclusive of screening period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
- 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- Have previously participated or withdrawn from this study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 Midazolam Midazolam Midazolam administered orally. Selpercatinib and Midazolam Midazolam Selpercatinib and midazolam administered orally. Selpercatinib and Midazolam Selpercatinib Selpercatinib and midazolam administered orally.
- Primary Outcome Measures
Name Time Method PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Midazolam Days 1, 2, 10, and 11 PK: AUC%extrap of Midazolam
PK: Maximum observed concentration (Cmax) of Midazolam Days 1, 2, 10, and 11 PK: Cmax of Midazolam
PK: Time to reach Cmax (Tmax) of Midazolam Days 1, 2, 10, and 11 PK: Tmax of Midazolam
Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Midazolam Days 1, 2, 10, and 11 PK: AUC0-t of Midazolam
PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Midazolam Days 1, 2, 10, and 11 PK: AUC0-inf of Midazolam
PK: Apparent first-order terminal elimination rate constant (Kel) of Midazolam Days 1, 2, 10, and 11 PK: Kel of Midazolam
PK: Apparent first-order terminal elimination half-life (t½) of Midazolam Days 1, 2, 10, and 11 PK: t½ of Midazolam
PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Midazolam Days 1, 2, 10, and 11 PK: CL/F of Midazolam
PK: Apparent volume of distribution during the terminal elimination phase (Vz/F) of Midazolam Days 1, 2, 10, and 11 PK: Vz/F of Midazolam
- Secondary Outcome Measures
Name Time Method PK: Concentration observed at the end of the dosing interval (Ctrough) of Selpercatinib Days 1-11 PK: Ctrough of Selpercatinib
PK: Apparent total plasma clearance (CL,ss/F) of Selpercatinib Days 1-11 PK: CL,ss/F of Selpercatinib
PK: Cmax of Selpercatinib Days 1-11 PK: Cmax of Selpercatinib
PK: Maximum observed concentration at steady-state (Cmax,ss) of Selpercatinib Days 1-11 PK: Cmax,ss of Selpercatinib
PK: Time to reach Cmax,ss (Tmax,ss) of Selpercatinib Days 1-11 PK: Tmax,ss of Selpercatinib
PK : Area under the concentration-time curve, from time 0 to the 12 hour (AUC0-12) of Selpercatinib Day 1 PK: AUC0-12 of Selpercatinib
PK: Tmax of Selpercatinib Days 1-11 PK: Tmax of Selpercatinib
PK: Area under the concentration-time curve during a dosing interval (tau) at steady state (AUCtau) of Selpercatinib Days 1-11 AUCtau of Selpercatinib
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States