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

Part of paid clinical trials in Miami, Florida.

Sponsor
Corcept Therapeutics
Study ID
NCT05347979
Phase
PHASE1
Status
Completed

Conditions

  • Cushing Syndrome
  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

First listed
Apr 27, 2022
Start date
May 25, 2022
Status verified
Feb 2023
Primary completion
Jul 19, 2022
Completion
Jul 19, 2022

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dabigatran Etexilate (NIMP) and Relacorilant (IMP)
    Following an overnight fast, participants will receive 75 mg dabigatran etexilate on Day 1, 400 mg dose of relacorilant QD on Days 3 to 13, and 75 mg dabigatran etexilate on Day 12. On Day 12, dabigatran etexilate will be dosed at approximately the same time as the relacorilant dose.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Dabigatran When Administered With and Without Relacorilant [ Time Frame: Up to Day 14 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Site 01MiamiFlorida33126-

Find similar trials in Miami, FL

By research site
Site 01· Miami, FL

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