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

Healthy Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04795479
Study type Interventional
Source Corcept Therapeutics
Contact
Status Completed
Phase Phase 1
Start date January 22, 2021
Completion date July 13, 2021
View Details
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