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Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

Sponsor
Tobias Else (Other)
Overall Status
Recruiting
CT.gov ID
NCT04588688
Collaborator
Corcept Therapeutics (Industry)
26
Enrollment
1
Location
1
Arm
26.9
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
Actual Study Start Date :
May 5, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mifepristone

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
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.
Other Names:
  • KORLYM®, C1073, RU486

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of study participants recruited [Study completion, approximately 36 months]

    2. Number of study participants with complete study data captured [Study completion, approximately 36 months]

    Secondary Outcome Measures

    1. Peak cortisol measured [Day 2]

      Serum cortisol will be collected the day after mifepristone administration and insulin tolerance test insulin tolerance test (ITT) if available

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria (1 of the following):

    • 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.

    Exclusion Criteria:

    • 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48108

    Sponsors and Collaborators

    • Tobias Else
    • Corcept Therapeutics

    Investigators

    • Principal Investigator: Tobias Else, MD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tobias Else, Assistant Professor, Department of Internal Medicine, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT04588688
    Other Study ID Numbers:
    • HUM00160641
    First Posted:
    Oct 19, 2020
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tobias Else, Assistant Professor, Department of Internal Medicine, University of Michigan
    Insulin Tolerance Test
    Additional relevant MeSH terms:
    Adrenal Insufficiency
    Mifepristone

    Study Results

    No Results Posted as of May 9, 2022