Evaluate Pharmacokinetics and Safety of Slow Release DHEA

NCT05623059 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 15038P01HL158507
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Asthma; Genotype

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 Outcomes (5)

• 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)

  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)

  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

  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).

  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.

  From administration of the first dose to 12 hours after the final dose (up to 59 days)

Study Arms (2)

50mg dose

OTHER

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

100mg dose

OTHER

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

Interventions

Slow Release DHEA DRUG

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.

Also known as: Slow Release Dehydroepiandrosterone

100mg dose; 50mg dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

University Hospital

Indianapolis, Indiana, 46202, United States

Location

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: This is an unblinded pharmacokinetic (PK) study to determine optimal dosing for future studies. This study 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.

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 21, 2022
• Study Start: March 3, 2023
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

US (2)