MedTrace Logo

Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s

NCT03457597 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-05-17

No results posted yet for this study

Summary

This is an open-label, single-sequence, 3-period crossover study conducted in healthy subjects. Eligible subjects will participate in a single treatment period, in which they will receive the following treatments: Day 1, single doses of midazolam and metoprolol; Day 2, single doses of pioglitazone, tolbutamide, and omeprazole; Days 5 to 17, daily doses of relacorilant; Day 14, single doses of midazolam and metoprolol (with relacorilant); and, Day 15, single doses of pioglitazone, tolbutamide, and omeprazole (with relacorilant).

Conditions

  • Healthy

Interventions

DRUG

Midazolam hydrochloride

Midazolam hydrochloride 2.5 mg

DRUG

Metoprolol tartrate

Metoprolol tartrate 100 mg

DRUG

Pioglitazone hydrochloride

Pioglitazone hydrochloride 15 mg

DRUG

Tolbutamide

Tolbutamide 500 mg

DRUG

Omeprazole

Omeprazole 20 mg

DRUG

Relacorilant

Relacorilant 350mg

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Kirsteen Donaldson, FFPM,DM,FRCP · Corcept Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-06
Primary Completion
2018-04-15
Completion
2018-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03457597 on ClinicalTrials.gov