A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant

Part of paid clinical trials in Miami, Florida.

Sponsor
Corcept Therapeutics
Study ID
NCT06094725
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Relacorilant — DRUG
    Relacorilant 300 mg (3 X 100 mg softgel capsules) for oral administration

Study Details

The primary objective of this multiple-dose, adaptive design study is to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of relacorilant relative to healthy matched control male and female subjects (Part 1).

Key Dates

First listed
Oct 23, 2023
Start date
Jan 6, 2020
Status verified
Oct 2023
Primary completion
Dec 14, 2020
Completion
Dec 14, 2020

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: No Hepatic Impairment
    Subjects with no hepatic impairment will receive relacorilant 300 mg once daily on Days 1 through 10.
  • Experimental: Moderate Hepatic Impairment
    Subjects with moderate hepatic impairment (Child-Pugh Class B) will receive relacorilant 300 mg once daily on Days 1 through 10.
  • Experimental: Mild Hepatic Impairment
    Subjects with mild hepatic impairment (Child-Pugh Class A) will receive relacorilant 300 mg once daily on Days 1 through 10.

Primary Outcome Measure

Maximum concentration of plasma relacorilant during the dosing interval (Cmax) [ Time Frame: Predose and at serial time points up to 24 hours after dosing on Day 10 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of Miami, LLCMiamiFlorida33014-
Orlando Clinical Research CenterOrlandoFlorida32809-

Find similar trials in Miami, FL

By research site
Clinical Pharmacology of Miami, LLC· Miami, FLOrlando Clinical Research Center· Orlando, FL

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