Evaluate Pharmacokinetics and Safety of Slow Release DHEA (DHEA)

July 7, 2025 updated by: Kirsten Kloepfer, Indiana University

Phase IIa Clinical Trial to Evaluate Pharmacokinetics and Safety of Slow Release DHEA

This is a study to look at pharmacokinetic levels of different doses of slow release DHEA in subjects with asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pharmacokinetic (PK) studies of DHEA in asthma have never been done. In many diseases, PK in subjects with disease differs from that of control subjects and those with other conditions. Therefore, researchers are investigating if PK levels of slow release DHEA are different in subjects with asthma who have the HSD3B1 AA or AC phenotypes

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children
      • Indianapolis, Indiana, United States, 46202
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult male or female aged between 18 and 50 at time of enrollment
  • Evidence of asthma demonstrated by reversibility at visit 0 or by historical methacholine or bronchodilator reversibility if testing was performed under either the 2017 ERS technical standard (22) or the 1999 ATS Guidelines (23) or outside studies, provided that full sets of flow volume loops have been reviewed and approved by the PI. These criteria are defined as one of the following:
  • For bronchodilator reversibility: An increase in FEV1 ≥10% (24) compared to the baseline (and 200 ml) after up to 8 puffs of albuterol
  • For historical methacholine responsiveness: Positive methacholine defined as PC20 ≤ 16 mg/ml, or PD20 ≤400 mcg
  • Physician diagnosis of asthma according to NHLBI guidelines;
  • Consistent use of an ICS/LABA inhaler for the prior 2 months;
  • Non smoker;
  • Females must not be pregnant or lactating;
  • Absence of non-allergic comorbidities;
  • Genotype testing positive for either HSD3B1 AA or AC specific variant

Exclusion Criteria:

  • Pregnant or actively trying to become pregnant; breastfeeding
  • positive urine pregnancy test
  • Known lung disease other than asthma
  • Acute (non asthma-related) dyspnea, viral respiratory illness or asthma exacerbation within 4 weeks of screening
  • Systemic glucocorticoid dosing for maintenance >10 mg/day of prednisone or equivalent
  • Patients with significant non-allergic comorbidities (e.g. cerebral palsy, heart disease, kidney disease, liver disease, etc.)
  • Patients with any know central or peripheral endocrine abnormality such as precocious puberty or diabetes
  • Patients with any known previous adverse reaction to DHEA
  • Current smoker or pack year history > 5 years (includes vaping/nicotine inhalation devices)
  • Positive urine cotinine test (> 100 mg/mL)
  • Use of prednisone or antibiotics in the last 4 weeks
  • Use of any performance-enhancing drugs in the last 2 weeks
  • Use of DHEA in the last 2 weeks
  • Androgen use for any reason
  • HSD3B1 CC phenotype
  • Any other condition or finding that would compromise the safety of the subject or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the PI
  • Menopausal amenorrhea by history
  • Positive PSA (>4 ng/ml) (Prostate Specific Antigen)
  • Prior diagnosis of vocal cord dysfunction, bronchopulmonary dysplasia, cystic fibrosis, chronic obstructive pulmonary disorder, or other lung disease
  • Systolic blood pressure > 150 mm Hg and/or diastolic blood pressure >90 mm Hg
  • Heart rates outside the range of 50 to 120 beats per minutes or with a pathologic irregularity
  • Patients afflicted with any additional acute or chronic pathology that in the opinion of the screening physician makes them unsuitable for study or increases the risks associated with the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 50mg dose
This arm will start with a one-time dose and progress to twice daily dosing for 3 days, every 12 hours. Study cohort will be 9 subjects with asthma. DHEA dose will be 50 mg via slow release capsules. Endpoints will be serum DHEA and DHEA-S levels at 10, 20, 30, 60 min & 2, 4, 6, 8, 12h after administration. After a one-week washout period, the protocol will be repeated using 100 mg of SR-DHEA.
Drug: Slow Release DHEA
DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
Other Names:
  • Slow Release Dehydroepiandrosterone
Other: 100mg dose
This arm will start with a one-time 100mg dose and progress to twice daily dosing for 3 days, every 12 hours. Study cohort will be same 9 subjects with asthma. DHEA dose will be 100mg via slow release capsules. Endpoints will be serum DHEA and DHEA-S levels at 10, 20, 30, 60 min & 2, 4, 6, 8, 12h after administration.
Drug: Slow Release DHEA
DHEA is a hormone produced by the body's adrenal gland. In drug form, it is available as an over-the-counter supplement that is available on the market without prescription.
Other Names:
  • Slow Release Dehydroepiandrosterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the maximum tolerated dose for slow release DHEA in asthmatic subjects on a single and recurring regimen of 50mg and of 100mg by pharmacokinetic evaluation.
Time Frame: From baseline to 12 hours after the final dose (up to 66 days)
The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by measuring the presence in and difference of pharmacokinetics of two dose levels (50mg and 100mg).
From baseline to 12 hours after the final dose (up to 66 days)
Determine the maximum tolerated dose for slow release DHEA for asthmatic subjects on a regimen of 50mg and 100mg by adverse event evaluation.
Time Frame: From administration of the first dose to 12 hours after the final dose (up to 59 days)]
The objective is to determine the maximum tolerated dose of slow release DHEA in patients with asthma and AA or AC genotype by evaluating the occurrences and severity of adverse events during or after dosing at two levels (5omg and 100mg).
From administration of the first dose to 12 hours after the final dose (up to 59 days)]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability evaluation measured by the change in vital signs from baseline to post-treatment (Vital signs will include heart-rate, respiratory rate, RA saturation)
Time Frame: From baseline to after the first washout period (up to 63 days)]
The objective is to evaluate the safety and tolerability of slow release DHEA in asthma by measuring the change in vital signs from before treatment to after treatment.
From baseline to after the first washout period (up to 63 days)]
Safety and tolerability evaluation measured by a change in physical symptoms from baseline to post-treatment. Physical symptoms will include reports such as cough, shortness of breath, chest tightness, wheeze)
Time Frame: From baseline to after the first washout period (up to 63 days)]
The objective is to evaluate the safety and tolerability of slow release DHEA in asthma by measuring the change in physical symptoms from before treatment to after treatment.
From baseline to after the first washout period (up to 63 days)]
Safety and tolerability evaluation measured by the change in physical exam findings from baseline to post-treatment
Time Frame: From baseline to after the first washout period (up to 63 days)
The objective is to evaluate the safety and tolerability of slow release DHEA in asthma by measuring the change in physical exam findings from before treatment to after treatment.
From baseline to after the first washout period (up to 63 days)
Safety and tolerability evaluation measured by the change in FEV from baseline to post-treatment (as measured by spirometry).
Time Frame: From baseline to after the first washout period (up to 63 days)
The objective is to evaluate the safety and tolerability of slow release DHEA in asthma patients by performing pulmonary function testing to obtain measurements of FEV (forced expiratory volume) before treatment and after treatment.
From baseline to after the first washout period (up to 63 days)
Safety and tolerability evaluation measured by the occurrence of an asthma exacerbation event during and after treatment.
Time Frame: From administration of the first dose to 12 hours after the final dose (up to 59 days)
The objective is to evaluate the safety and tolerability of slow release DHEA in asthma patients by recording any instance of asthma exacerbation event during or after treatment.
From administration of the first dose to 12 hours after the final dose (up to 59 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Actual)

April 24, 2025

Study Completion (Actual)

April 24, 2025

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15038
  • P01HL158507 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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