Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

NCT04588688 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: HUM00160641
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers propose the use of mifepristone as an alternative way to test for Central Adrenal Insufficiency (CAI). They want to assess the feasibility of recruitment and the efficacy of the purposed method.

Conditions

Central Adrenal Insufficiency; Mifepristone

Keywords

Insulin Tolerance Test

Outcome Measures

Primary Outcomes (2)

• Number of Study Participants Recruited

  Because this was a feasibility trial, the goal was to see how many participants could be successfully recruited. The original intent was for the recruitment period to be for 36 months, with a target enrollment of 26 participants. The trial opened for recruitment on February 17, 2020. Because of low enrollment, the decision to terminate was made on September 7, 2022, approximately 30 months later.

  Up to 88 days

• Number of Study Participants With Complete Study Data Captured

  Because this was a feasibility trial, the goal was to see how many participants could be successfully recruited. The original intent was for the recruitment period to be for 36 months, with a target enrollment of 26 participants. Because of low enrollment, the decision to terminate was made after the trial had been open for recruitment for approximately 30 months (February 17, 2020 - September 7, 2022).

  30 days

Secondary Outcomes (2)

• Peak Cortisol Measured After Mifepristone

  Day 2 (day after mifepristone administration)

• Absolute ACTH After Mifepristone

  Day 2 (day after mifepristone administration)

Study Arms (1)

Mifepristone

EXPERIMENTAL

Patients will be provided a single dose of 600 milligram (mg) mifepristone to be administered orally, and subjects will be instructed to take the drug between 10PM and 11PM on Day 1.

Drug: Mifepristone

Interventions

Mifepristone DRUG

Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor.

Also known as: KORLYM®, C1073, RU486

Mifepristone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed insulin tolerance testing (ITT) at University of Michigan from 2012 to present.
• Are scheduled to complete ITT.
• Are clinically suspected to have adrenal insufficiency but have not undergone ITT.

You may not qualify if:

• Female patients who are of child-bearing potential (defined as a sexually mature woman who has not undergone hysterectomy, bilateral oophorectomy bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 12 weeks prior to screening, or who has not been naturally postmenopausal for at least 24 consecutive months prior to study enrollment) and not using non-hormonal contraception.
• Female patients not willing to use non-hormonal contraception for one month following treatment.
• Women who are pregnant or breast feeding.
• Patients with an existing diagnosis of adrenal insufficiency who are on any glucocorticoid replacement other than oral hydrocortisone or prednisone.
• Patients on medications that are strong CYP3A
• Patients taking other medications metabolized by CYP3A
• Patients who have a history of QT prolongation and patients with any recent abnormal electrocardiogram (ECG).

Sponsors & Collaborators

• Tobias Else: lead
• Corcept Therapeutics: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Tobias Else
• Organization: University of Michigan

telse@med.umich.edu

734-936-1319

Study Officials

• Tobias Else, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Internal Medicine

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: May 5, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 12, 2023
• Results First Posted: June 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)