NCT03512548

Study in Healthy Subjects to Determine the Effect of an Inhibitor on Exposure to Relacorilant and Its Metabolites

Completed Phase 1 Last updated 24 March 2020

What this trial tests

Phase 1 trial testing Relacorilant 350mg in Healthy in 52 participants. Completed in 23 August 2019.

Timeline

10 April 2018

Primary endpoint
29 July 2019

23 August 2019

Quick facts

Lead sponsor	Corcept Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	52
Start date	10 April 2018
Primary completion	29 July 2019
Estimated completion	23 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Relacorilant 350mg — full drug profile →
• Itraconazole — full drug profile →
• Relacorilant 300mg — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Corcept Therapeutics — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and continued once daily 200-mg doses of itraconazole for three additional days.

If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in combination with once daily 200-mg doses of itraconazole for 10 days.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. PMON165 Favorable Liver Safety Profile of the Selective Glucocorticoid Receptor Modulator Relacorilant in Healthy and Hepatically Impaired Adults and in Patients with Cushing Syndrome
   · 2022