A Study of Effects of Selpercatinib (LY3527723) on Repaglinide in Healthy Participants
- Registration Number
- NCT05469113
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to assess the effect of selpercatinib on how fast repaglinide 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 12 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
- 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
- Hemoglobin (Hb) A1c value < 6.5 % at screening and fasting glucose ≤ 126 mg/dL.
- Males who are capable of fathering a child must agree to use one of the following methods of contraception from the time of the dose administration through 6 months after the last dose
- Female of non-childbearing potential only or must have undergone sterilization procedures at least 6months prior to the first dosing
Exclusion Criteria
- History or presence of diabetes or history of prior episode(s) of hypoglycemia.
- Estimated creatinine clearance <90 mL/min at Screening or Check-in (Day -1, Period 1)
- Unable to refrain from or anticipates the use of any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements for 14 days prior to the first dosing and through EOT or ET. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Repaglinide - Period 1 Repaglinide Single dose of repaglinide administered orally. Selpercatinib and repaglinide - Period 2 Repaglinide Multiple doses of selpercatinib along with single dose of repaglinide administered orally. There will be a 24-hour washout period between Period 1 and 2. Selpercatinib and repaglinide - Period 2 Selpercatinib Multiple doses of selpercatinib along with single dose of repaglinide administered orally. There will be a 24-hour washout period between Period 1 and 2.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Repaglinide Pre-dose up to 16 hours postdose PK: AUC0-t of Repaglinide
PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Repaglinide Pre-dose up to 16 hours post-dose PK: AUC0-inf of Repaglinide
PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Repaglinide Pre-dose up to 16 hours post-dose PK: AUC%extrap of Repaglinide
PK: Maximum observed concentration (Cmax) of Repaglinide Pre-dose up to 16 hours post-dose PK: Cmax of Repaglinide
PK: Time to reach Cmax (Tmax) of Repaglinide Pre-dose up to 16 hour post-dose PK: Tmax of Repaglinide
PK: Apparent first-order terminal elimination rate constant (Kel) of Repaglindide Pre-dose up to 16 hour post-dose PK: Kel of Repaglindide
PK: Apparent first-order terminal elimination half-life (t½) of Repaglinide Pre-dose up to 16 hour post-dose PK: t½ of Repaglinide
PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Repaglinide Pre-dose up to 16 hour post-dose PK: CL/F of Repaglinide
PK: Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F) of Repaglinide Pre-dose up to 16 hour post-dose PK: (Vz/F) of Repaglinide
- Secondary Outcome Measures
Name Time Method PK: Area under the concentration-time curve, from time 0 to the 12 hour timepoint (AUC0-12) of Selpercatinib (Day 1 of Period 2) Pre-morning dose up to 12 hours following the morning dose PK: AUC0-12 of Selpercatinib
PK: Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib (Day 1 of Period 2) Pre-morning dose up to 12 hours following the morning dose PK: AUC0-t of Selpercatinib
PK: Maximum observed concentration (Cmax) of Selpercatinib (Day 1 of Period 2) Pre-morning dose up to 12 hours following the morning dose PK: Cmax of Selpercatinib
PK: Time to reach Cmax (Tmax) of Selpercatinib (Day 1 of Period 2) Pre-morning dose up to 12 hours following the morning dose PK: Tmax of Selpercatinib
PK: Area under the concentration-time curve during a dosing interval (tau) at steady state (AUCtau) of Selpercatinib (Day 10 of Period 2) Pre-morning dose up to 12 hours following the morning dose PK: AUCtau of Selpercatinib
PK: Maximum observed concentration at steady-state (Cmax,ss) of Selpertcatinib (Day 10 of Period 2) Pre-morning dose up to 12 hours following the morning dose PK: Cmax,ss of Selpertcatinib
PK: Concentration observed at the end of the dosing interval (Ctrough) of Selpercatinib (Day 10 of Period 2) Pre-morning dose PK: Ctrough of Selpercatinib
PK: Time to reach Cmax,ss (Tmax,ss) of Selpercatinib (Day 10 of Period 2) Pre-morning dose up to 12 hours following the morning dose PK: Tmax,ss of Selpercatinib
PK: Apparent total plasma clearance after oral (extravascular) administration(CL,ss/F) of Selpercatinib (Day 10 of Period 2) Pre-morning dose up to 12 hours following the morning dose PK: CL,ss/F of Selpercatinib
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States