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
Abstract
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.
Conditions: Healthy.
Primary outcome: Cardiodynamics: Placebo-corrected Change From Baseline in QT Interval Corrected Using Fridericia's Correction (QTcF) (ΔΔQTcF) for Treatments A, B, and C; 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: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib; PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib; PK: Maximum Observed Concentration (Cmax) of Selpercatinib; PK: Time to Reach Cmax (Tmax) of Selpercatinib; PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib; PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib.
Enrollment: 32 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 32 participants or records.
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