NCT04607512

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Cardiac Safety

Interventions

Type	Name	Description
DRUG	telaglenastat	glutaminase inhibitor
OTHER	telaglenastat placebo	matching placebo for telaglenastat
OTHER	moxifloxicin	positive control

Timeline

• Start date: 2020-10-05
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2020-10-29
• Last updated: 2021-03-09

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study