Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 37 of 236 for:    PRASTERONE

Studies of Sulfur Metabolism in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03383133
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Leyh, Albert Einstein College of Medicine

Brief Summary:
The study test whether the NSAID allosteric site of human sulfotransferase 1A1 (SULT1A1) is operative in humans. The study will test the effects of mefenamic acid (MEF) on the sulfonation of acetaminophen (APAP, a SULT1A1 specific substrate) and dehydroepiandrosterone (DHEA, a SULT2A1 substrate). If the allosteric site is active in vivo, MEF is predicted to result in a decrease in sulfonation of APAP (MEF inhibits SULT with high affinity (Ki = 23 nM), and to have no effect on sulfonation of the DHEA (MEF has little or no effect on SULT2A1 activity).

Condition or disease Intervention/treatment Phase
Metabolic Side Effects of Drugs Drug: SULT Allosteric Inhibition Early Phase 1

Detailed Description:

No patient registries associated with this study.

A single, therapeutic dose of acetaminophen (APAP, 1.0 g)) or dehydroepiandrosterone (DHEA, 75 mg) is taken orally (with 375 ml of water) either alone or simultaneously with a single, oral, therapeutic dose of mefenamic acid (MEF, 0.75 g). In total, 5 experiments will be performed: 1, APAP alone; 2, DHEA alone; 3, MEF alone; 4, APAP + MEF; and 5, DHEA + MEF. Each experiment will be performed in duplicate. Compounds will be taken prior to eating breakfast. One hour later, the patient has a light breakfast (Cheerios and milk, and a cup of coffee) and eats normally thereafter. Urine samples are collected at 15', 30', 1 h, 2h, 3h, 4h, 5 h, 6h, 7h, 8h, 9h, 10h, 11h, and 12h intervals following dosing. The study subject will attempt to completely empty their bladder at each urine-collection time point. The samples are weighed. A 10 ml aliquot is taken from each time point and the aliquots are stored at -20 °C. Samples (0.5 ml) are then transferred to NMR tubes and NMR spectra are taken to assess drug metabolites in urine. Proton NMR will be performed using the 600 MHz instrument in the Einstein facility.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study will involve only a single individual.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Allosteric Regulation of Cytosolic Sulfotransferases in Humans
Actual Study Start Date : January 11, 2018
Actual Primary Completion Date : March 31, 2019
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: SULT Allosteric Inhibition
A single, therapeutic dose of acetaminophen (1.0 g)) or dehydroepiandrosterone (75 mg) is taken orally (with 375 ml of water) either alone or simultaneously with a single, oral, therapeutic dose of mefenamic acid (0.75 g).
Drug: SULT Allosteric Inhibition
A single, therapeutic dose of acetaminophen (APAP, 1.0 g)) or dehydroepiandrosterone (DHEA, 75 mg) is taken orally (with 375 ml of water) either alone or simultaneously with a single, oral, therapeutic dose of mefenamic acid (MEF, 0.75 g). In total, 5 experiments will be performed. Each experiment is performed in duplicate. Compounds are taken prior to eating breakfast. One hour later, the patient has a light breakfast and eats normally thereafter. Urine samples are collected at 15', 30', 1 h, 2h, 3h, 4h, 5 h, 6h, 7h, 8h, 9h, 10h, 11h, and 12h intervals following dosing. The samples are weighed. A 10 ml aliquot is taken from each time point and the aliquots are stored at -20 °C. Samples (0.5 ml) are then transferred to NMR tubes spectra are taken to assess drug metabolites in urine.




Primary Outcome Measures :
  1. Acetaminophen and Dehydroepiandrosterone Conjugates [ Time Frame: 15min, 30min, 1hr, 2hr, 3hr, 4hr, 5hr, 6hr, 7hr, 8hr, 9hr, 10hr, 11hr, and 12hr following administration. ]
    Proton NMR Signals will be used to quantitate conjugates of acetaminophen and dehydroepiandrosterone in urine.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   61 Years to 61 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Gender - one male
  • Age - 61 y.o.
  • Healthy
  • Agreed to sign the consent form

Exclusion criteria:

● None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383133


Locations
Layout table for location information
United States, New York
Albert Einstein Collage of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Thomas S Leyh, Ph. D. The Albert Einstein College of Medicine

Publications:

Layout table for additonal information
Responsible Party: Thomas Leyh, Professor of Microbiology and Immunology, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03383133    
Other Study ID Numbers: 2017-8685
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study will determine the levels acetaminophen and dehydroepiandrosterone conjugates in the urine of a single individuals. The levels will be published and

Layout table for additional information
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.: Yes
Keywords provided by Thomas Leyh, Albert Einstein College of Medicine:
sulfotransferase
metabolism
acetaminophen
dehydroepiandrosterone
mefenamic acid
allostery
Additional relevant MeSH terms:
Layout table for MeSH terms
Dehydroepiandrosterone
Drug-Related Side Effects and Adverse Reactions
Metabolic Side Effects of Drugs and Substances
Chemically-Induced Disorders
Acetaminophen
Mefenamic Acid
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Adjuvants, Immunologic
Immunologic Factors
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action