A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Dose, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Way Crossover Study to Evaluate the Effect of LOXO-292 on the QTc Interval in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Selpercatinib
* Drug: Moxifloxacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selpercatinib (Dose level 1)<br>Selpercatinib administered as single dose orally. | Drug: Selpercatinib<br>* Administered orally<br>* Other names: LOXO-292;|
| Experimental: Selpercatinib (Dose level 2)<br>Selpercatinib administered as single dose orally. | Drug: Selpercatinib<br>* Administered orally<br>* Other names: LOXO-292;|
| Active Comparator: Moxifloxacin<br>Moxifloxacin administered as single dose orally. | Drug: Moxifloxacin<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Placebo administered orally. | Drug: Placebo<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiodynamics: Model Predicted Baseline-corrected and Placebo-corrected QT Interval Corrected Using Fridericia's Correction (QTcF)(ΔΔQTcF) | Cardiodynamics: Model Predicted Baseline-corrected and Placebo-corrected ΔΔQTcF | Pre-dose up to 24 hour post-dose | 
| 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 | PK: AUC0-t of Selpercatinib | Pre-dose up to 240 hour post-dose | 
| PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib | PK: AUC0-inf of Selpercatinib | Pre-dose up to 240 hour post-dose | 
| PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib | PK: AUC%extrap of Selpercatinib | Pre-dose up to 240 hour post-dose | 
| PK: Maximum observed concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib | Pre-dose up to 240 hour post-dose | 
| PK: Time to reach Cmax (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib | Pre-dose up to 240 hour post-dose | 
| PK: Apparent first order terminal elimination rate constant (Kel) of Selpercatinib | PK: Kel of Selpercatinib | Pre-dose up to 240 hour post-dose | 
| PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib | PK: t½ of Selpercatinib | Pre-dose up to 240 hour post-dose |