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Ketoconazole for Mild Autonomous Cortisol Secretion

This study is looking at how ketoconazole, a medication that can lower cortisol levels, affects people with Mild Autonomous Cortisol Secretion (MACS). MACS is a condition where your body makes too much cortisol, a hormone that normally goes down at night. Researchers believe that higher nighttime cortisol in MACS may contribute to problems like high blood pressure. The study will compare the daily cortisol rhythm in people with MACS to healthy volunteers. It will also test if a single dose of ketoconazole can help restore a more normal daily cortisol pattern in people with MACS. You can join if you are 18 or older and have MACS, or if you are a healthy volunteer. The study aims to understand the differences in cortisol rhythms and how ketoconazole might help.

Study design
This is an interventional study with a planned enrollment of 36 participants. It will compare cortisol rhythms in people with MACS to healthy volunteers.
What's involved
If you have MACS, you will have a 2-night stay in the hospital, including having a thin tube (catheter) inserted into a vein for blood sampling.
Compensation
Not stated in the trial record.
Follow-up
Cortisol levels will be measured during 24 hours at baseline and after receiving ketoconazole.

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NCT07649317

Ketoconazole Effects on the Daily Cortisol Rhythm in Mild Autonomous Cortisol Secretion

Recruiting
PHASE1Ages 18+InterventionalBasic science
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~36 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Ketoconazole

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched healthy volunteers (HV).
Measured over Baseline sampling obtained during 24 hours in each participant.

Conditions

Mild Autonomous Cortisol Secretion

Explore related trials

Healthy VolunteersMild Autonomous Cortisol Secretion

NCT07649317

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lynnette K Nieman, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who to contact

Raven N McGlotten, R.N.
[email protected]
(301) 827-0190
Email the study team

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Eligibility criteria

Inclusion

Age: Birth year within 5 years of that of the participant with MACS.
Sex
BMI (kg/m2) category: \<18.5 (underweight); 18.5-24.9 (normal weight); 25-29.9 (overweight); 30-34.9 (obesity class 1); 35-39.9 (obesity class 2); \>=40 (obesity class 3).
For women: menopausal status as judged by absence of menses for one year and FSH\>15 mIU/mL.

Exclusion

Prolong QT when combined with ketoconazole (KTZ):
Cause toxicity from increased concentration due to KTZ-induced CYP3A4 inhibition:
methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine.
Inhibit CYP3A4 and increase KTZ bioavailability:
Induce CYP3A4 and decrease KTZ bioavailability:
Isoniazid, rifabutin, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine. 7. Inability to pause, for 24 hours, use of medication that reduces KTZ absorption: proton pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole) and H2 antagonists (cimetidine, famotidine, nizatidine).

What this trial measures

  • To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched healthy volunteers (HV).Baseline sampling obtained during 24 hours in each participant.

    Difference in serum cortisol between MACS and HV at timepoints 1600h, 1800h, 2000h, 2200h, 0000h and 0200h during 24-hour sampling.