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NCT03457597 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Corcept Therapeutics.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT03457597 is a Phase 1 study that has completed, run by Corcept Therapeutics. The registered enrollment target is 27 participants.

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The verdict

NCT03457597, a Phase 1 study, has completed, sponsored by Corcept Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

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).

Interventions

  • DRUG Omeprazole
  • DRUG Tolbutamide
  • DRUG Metoprolol tartrate
  • DRUG Pioglitazone hydrochloride
  • DRUG Midazolam hydrochloride

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2018-03-06
Est. Completion 2018-04-28
Phase Phase 1

Sponsor

Corcept Therapeutics

54 total trials

What the Registry Record Tells You About NCT03457597

The ClinicalTrials.gov registry entry for NCT03457597 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corcept Therapeutics, which has 54 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Omeprazole is the first listed.

NCT03457597 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03457597 about?

NCT03457597 is a clinical study titled "Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s". 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, ...

What is the current status of trial NCT03457597?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2018-03-06. Estimated completion is 2018-04-28.

What interventions are being tested in trial NCT03457597?

The interventions under investigation include: Omeprazole (DRUG), Tolbutamide (DRUG), Metoprolol tartrate (DRUG), Pioglitazone hydrochloride (DRUG), Midazolam hydrochloride (DRUG).

Who is sponsoring clinical trial NCT03457597?

This trial is sponsored by Corcept Therapeutics, which has 54 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.