Study to Evaluate the ECG Effects of Telaglenastat in Healthy Adult Subjects

Cardiac Safety Clinical Trial

Official title: A Three-Way Crossover Study to Evaluate the ECG Effects of Telaglenastat in Healthy Adult Subjects

Status Completed

Clinical Trial Summary

This study is designed to evaluate the effects of telaglenastat on cardiac repolarization (relative to placebo) in healthy adult subjects.

Clinical Trial Description

This is a multiple-dose, randomized, double-blind (with respect to telaglenastat and placebo), placebo- and positive controlled, 3 way crossover thorough QT (TQT) study in healthy adult subjects.

On Day 1 of Period 1, subjects will be randomized to 1 of 6 treatment sequences.

In Treatments A and B, subjects will receive the assigned treatment on Day 1 through the morning of Day 4. In Treatment C, subjects will receive a single-dose administration of moxifloxacin in the morning of Day 4. Cardiodynamic readings will be collected for 24 hours on Days 1 and 4. Plasma PK samples will be collected prior to dosing (for Treatments A and B or Hour 0 for Treatment C) and up to 24 hours on Days 1 and 4 of all treatments. ;

Related Conditions & MeSH terms

• Cardiac Safety

• NCT number: NCT04607512
• Study type: Interventional
• Source: Calithera Biosciences, Inc
• Status: Completed
• Phase: Phase 1
• Start date: October 5, 2020
• Completion date: December 30, 2020