A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants
- Registration Number
- NCT05630274
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to assess the effect of Selpercatinib (LY3527723) on the heart rate-corrected QT (QTc) interval. The study will last up to 41 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- Healthy, adult, non-smoking, male or female (of non childbearing potential only or undergone sterilization procedures at least 6 months prior to the Screening)
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) at Screening and have a minimum weight of at least 50 kg at Screening
- Female of non childbearing potential: must have undergone sterilization procedures at least 6 months prior to the Screening
- Males who are capable of fathering a child must agree to use contraception from the time of the dose administration through 6 months after the last dose
Exclusion Criteria
- Estimated creatinine clearance <90 milliliter per minute (mL/min) at Screening or Check in (Day -1; rechecks will be permitted up to two times to confirm participant eligibility for study participation).
- Has serum potassium levels <3.8 milliequivalents per liter (mEq/L) at Screening or Check in (Day -1; rechecks will be permitted up to two times to confirm participant eligibility for study participation).
- Has serum calcium levels < 8.5 milligrams/deciliter (mg/dL) at Screening or Check in (Day -1; rechecks will be permitted up to two times to confirm participant eligibility for study participation).
- Has serum magnesium levels <2.0 mEq/L at Screening or Check in (Day -1; rechecks will be permitted up to two times to confirm participant eligibility for study participation)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Selpercatinib (Dose level 1) Selpercatinib Selpercatinib administered as single dose orally. Placebo Placebo Placebo administered orally. Selpercatinib (Dose level 2) Selpercatinib Selpercatinib administered as single dose orally. Moxifloxacin Moxifloxacin Moxifloxacin administered as single dose orally.
- Primary Outcome Measures
Name Time Method Cardiodynamics: Model Predicted Baseline-corrected and Placebo-corrected QT Interval Corrected Using Fridericia's Correction (QTcF)(ΔΔQTcF) Pre-dose up to 24 hour post-dose Cardiodynamics: Model Predicted Baseline-corrected and Placebo-corrected ΔΔQTcF
Pharmacokinetics (PK): Area under the concentration-time curve from time 0 to the time of the last observed non-zero concentration (AUC0-t) of Selpercatinib Pre-dose up to 240 hour post-dose PK: AUC0-t of Selpercatinib
PK: Maximum observed concentration (Cmax) of Selpercatinib Pre-dose up to 240 hour post-dose PK: Cmax of Selpercatinib
PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib Pre-dose up to 240 hour post-dose PK: t½ of Selpercatinib
PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib Pre-dose up to 240 hour post-dose PK: AUC0-inf of Selpercatinib
PK: Time to reach Cmax (Tmax) of Selpercatinib Pre-dose up to 240 hour post-dose PK: Tmax of Selpercatinib
PK: Apparent first order terminal elimination rate constant (Kel) of Selpercatinib Pre-dose up to 240 hour post-dose PK: Kel of Selpercatinib
PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib Pre-dose up to 240 hour post-dose PK: AUC%extrap of Selpercatinib
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States
Celerion🇺🇸Tempe, Arizona, United States