NCT05347979

Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Participants

An Open-Label, Drug-Drug Interaction Study Designed to Evaluate the Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to determine the effect of relacorilant on the pharmacokinetics (PK) of the sensitive P-glycoprotein (P-gp) substrate dabigatran etexilate.

Detailed description

The investigational medicinal product (IMP), relacorilant, and the non-investigational medicinal product (NIMP), dabigatran etexilate, will be used to evaluate the effect of relacorilant on the PK of the sensitive P-gp substrate, dabigatran etexilate in healthy participants. Participants will receive a single dose of dabigatran etexilate before and after administration of daily (QD) doses of relacorilant for 11 days. As all participants will receive the same treatments, the study will be open-label and no randomization is required.

Conditions

• Cushing Syndrome
• Neoplasms

Interventions

Type	Name	Description
DRUG	Dabigatran Etexilate	Dabigatran will be administered orally as a 75 mg capsule on Day 1 and Day 12.
DRUG	Relacorilant	Relacorilant will be administered orally as 4 X 100 mg capsules (400 mg) on Days 3 through 13.

Timeline

• Start date: 2022-05-25
• Primary completion: 2022-07-19
• Completion: 2022-07-19
• First posted: 2022-04-27
• Last updated: 2023-02-09

Locations

1 site across 1 country: United States