Studies of Sulfur Metabolism in Humans
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| ClinicalTrials.gov Identifier: NCT03383133 |
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Recruitment Status :
Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : January 5, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metabolic Side Effects of Drugs | Drug: SULT Allosteric Inhibition | Early Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1 participants |
| Allocation: | N/A |
| 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 : | December 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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).
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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. |
- 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.
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| Ages Eligible for Study: | 61 Years to 61 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Gender - one male
- Age - 61 y.o.
- Healthy
- Agreed to sign the consent form
Exclusion criteria:
● None
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
| United States, New York | |
| Albert Einstein Collage of Medicine | |
| Bronx, New York, United States, 10461 | |
| Principal Investigator: | Thomas S Leyh, Ph. D. | The Albert Einstein College of Medicine |
| Responsible Party: | 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 5, 2022 |
| Last Verified: | January 2022 |
| 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 |
| 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 |
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sulfotransferase metabolism acetaminophen |
dehydroepiandrosterone mefenamic acid allostery |
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Drug-Related Side Effects and Adverse Reactions Metabolic Side Effects of Drugs and Substances Chemically-Induced Disorders |