NCT04795479

T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers

A Randomized, Partial Double-Blind, Placebo- and Positive- Controlled, Multiple-Dose, 4-Way Crossover, Thorough QT/QTc (TQT) Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This dedicated T/QT study will investigate the effect of relacorilant on cardiac repolarization in healthy participants.

Detailed description

This four-period crossover study with 12 treatment sequences includes relacorilant administered at therapeutic (400 mg once daily \[QD\]) and supra-therapeutic (800 mg QD) doses, placebo for relacorilant as a negative control, and oral moxifloxacin as a positive control. The positive control will serve to determine the sensitivity of the assay to detect small increases from baseline in the QTc interval. Each of the four treatment periods will last 5 days with a washout of at least 10 days between periods. Relacorilant and placebo to relacorilant will be administered double-blind; moxifloxacin will be administered open label.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Relacorilant	Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
DRUG	Placebo to relacorilant	Placebo to relacorilant capsule by mouth once daily
DRUG	Moxifloxacin	Moxifloxacin 400 mg tablet by mouth

Timeline

• Start date: 2021-01-22
• Primary completion: 2021-05-17
• Completion: 2021-07-13
• First posted: 2021-03-12
• Last updated: 2021-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study