Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-01-29 @ 11:21 PM
Study NCT ID:
NCT05623059
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2022-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Pharmacokinetics and Safety of Slow Release DHEA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-24', 'size': 280066, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-24T15:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'From baseline to 12 hours after the final dose (up to 66 days)', 'description': '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).'}, {'measure': 'Determine the maximum tolerated dose for slow release DHEA for asthmatic subjects on a regimen of 50mg and 100mg by adverse event evaluation.', 'timeFrame': 'From administration of the first dose to 12 hours after the final dose (up to 59 days)]', 'description': '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).'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': 'From baseline to after the first washout period (up to 63 days)]', 'description': '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.'}, {'measure': '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)', 'timeFrame': 'From baseline to after the first washout period (up to 63 days)]', 'description': '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.'}, {'measure': 'Safety and tolerability evaluation measured by the change in physical exam findings from baseline to post-treatment', 'timeFrame': 'From baseline to after the first washout period (up to 63 days)', 'description': '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.'}, {'measure': 'Safety and tolerability evaluation measured by the change in FEV from baseline to post-treatment (as measured by spirometry).', 'timeFrame': 'From baseline to after the first washout period (up to 63 days)', 'description': '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.'}, {'measure': 'Safety and tolerability evaluation measured by the occurrence of an asthma exacerbation event during and after treatment.', 'timeFrame': 'From administration of the first dose to 12 hours after the final dose (up to 59 days)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma', 'Genotype']}, 'referencesModule': {'references': [{'pmid': '20422063', 'type': 'BACKGROUND', 'citation': 'Sadatsafavi M, Lynd L, Marra C, Carleton B, Tan WC, Sullivan S, Fitzgerald JM. 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Epub 2013 Dec 12.'}, {'pmid': '2850875', 'type': 'BACKGROUND', 'citation': 'Watson AC, Rosenfield RL, Fang VS. Recovery from glucocorticoid inhibition of the responses to corticotrophin-releasing hormone. Clin Endocrinol (Oxf). 1988 May;28(5):471-7. doi: 10.1111/j.1365-2265.1988.tb03681.x.'}, {'pmid': '19874391', 'type': 'BACKGROUND', 'citation': 'Jollin L, Thomasson R, Le Panse B, Baillot A, Vibarel-Rebot N, Lecoq AM, Amiot V, De Ceaurriz J, Collomp K. Saliva DHEA and cortisol responses following short-term corticosteroid intake. Eur J Clin Invest. 2010 Feb;40(2):183-6. doi: 10.1111/j.1365-2362.2009.02219.x. Epub 2009 Oct 29.'}, {'pmid': '28920065', 'type': 'BACKGROUND', 'citation': 'Al-Tarrah K, Moiemen N, Lord JM. The influence of sex steroid hormones on the response to trauma and burn injury. 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Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.'}, {'pmid': '9872837', 'type': 'BACKGROUND', 'citation': 'Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.'}, {'pmid': '17983880', 'type': 'BACKGROUND', 'citation': 'National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to look at pharmacokinetic levels of different doses of slow release DHEA in subjects with asthma.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female aged between 18 and 50 at time of enrollment\n* 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:\n* For bronchodilator reversibility: An increase in FEV1 ≥10% (24) compared to the baseline (and 200 ml) after up to 8 puffs of albuterol\n* For historical methacholine responsiveness: Positive methacholine defined as PC20 ≤ 16 mg/ml, or PD20 ≤400 mcg\n* Physician diagnosis of asthma according to NHLBI guidelines;\n* Consistent use of an ICS/LABA inhaler for the prior 2 months;\n* Non smoker;\n* Females must not be pregnant or lactating;\n* Absence of non-allergic comorbidities;\n* Genotype testing positive for either HSD3B1 AA or AC specific variant\n\nExclusion Criteria:\n\n* Pregnant or actively trying to become pregnant; breastfeeding\n* positive urine pregnancy test\n* Known lung disease other than asthma\n* Acute (non asthma-related) dyspnea, viral respiratory illness or asthma exacerbation within 4 weeks of screening\n* Systemic glucocorticoid dosing for maintenance \\>10 mg/day of prednisone or equivalent\n* Patients with significant non-allergic comorbidities (e.g. cerebral palsy, heart disease, kidney disease, liver disease, etc.)\n* Patients with any know central or peripheral endocrine abnormality such as precocious puberty or diabetes\n* Patients with any known previous adverse reaction to DHEA\n* Current smoker or pack year history \\> 5 years (includes vaping/nicotine inhalation devices)\n* Positive urine cotinine test (\\> 100 mg/mL)\n* Use of prednisone or antibiotics in the last 4 weeks\n* Use of any performance-enhancing drugs in the last 2 weeks\n* Use of DHEA in the last 2 weeks\n* Androgen use for any reason\n* HSD3B1 CC phenotype\n* 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\n* Menopausal amenorrhea by history\n* Positive PSA (\\>4 ng/ml) (Prostate Specific Antigen)\n* Prior diagnosis of vocal cord dysfunction, bronchopulmonary dysplasia, cystic fibrosis, chronic obstructive pulmonary disorder, or other lung disease\n* Systolic blood pressure \\> 150 mm Hg and/or diastolic blood pressure \\>90 mm Hg\n* Heart rates outside the range of 50 to 120 beats per minutes or with a pathologic irregularity\n* 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.'}, 'identificationModule': {'nctId': 'NCT05623059', 'acronym': 'DHEA', 'briefTitle': 'Evaluate Pharmacokinetics and Safety of Slow Release DHEA', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Phase IIa Clinical Trial to Evaluate Pharmacokinetics and Safety of Slow Release DHEA', 'orgStudyIdInfo': {'id': '15038'}, 'secondaryIdInfos': [{'id': 'P01HL158507', 'link': 'https://reporter.nih.gov/quickSearch/P01HL158507', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '50mg dose', 'description': '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.', 'interventionNames': ['Drug: Slow Release DHEA']}, {'type': 'OTHER', 'label': '100mg dose', 'description': '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.', 'interventionNames': ['Drug: Slow Release DHEA']}], 'interventions': [{'name': 'Slow Release DHEA', 'type': 'DRUG', 'otherNames': ['Slow Release Dehydroepiandrosterone'], 'description': "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.", 'armGroupLabels': ['100mg dose', '50mg dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Kirsten Kloepfer', 'investigatorAffiliation': 'Indiana University'}}}}