Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
1 participants
INTERVENTIONAL
2018-01-11
2023-02-02
Brief Summary
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Detailed Description
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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 nuclear magnetic resonance (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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age - 61 y.o.
* Healthy
* Agreed to sign the consent form
Exclusion Criteria
61 Years
61 Years
MALE
No
Sponsors
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Albert Einstein College of Medicine
OTHER
Responsible Party
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Principal Investigators
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Thomas S Leyh, Ph. D.
Role: PRINCIPAL_INVESTIGATOR
The Albert Einstein College of Medicine
Locations
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Albert Einstein Collage of Medicine
The Bronx, New York, United States
Countries
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References
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Falany JL, Macrina N, Falany CN. Regulation of MCF-7 breast cancer cell growth by beta-estradiol sulfation. Breast Cancer Res Treat. 2002 Jul;74(2):167-76. doi: 10.1023/a:1016147004188.
Parker CR Jr. Dehydroepiandrosterone and dehydroepiandrosterone sulfate production in the human adrenal during development and aging. Steroids. 1999 Sep;64(9):640-7. doi: 10.1016/s0039-128x(99)00046-x.
Cook IT, Duniec-Dmuchowski Z, Kocarek TA, Runge-Morris M, Falany CN. 24-hydroxycholesterol sulfation by human cytosolic sulfotransferases: formation of monosulfates and disulfates, molecular modeling, sulfatase sensitivity, and inhibition of liver x receptor activation. Drug Metab Dispos. 2009 Oct;37(10):2069-78. doi: 10.1124/dmd.108.025759. Epub 2009 Jul 9.
Visser TJ. Role of sulfation in thyroid hormone metabolism. Chem Biol Interact. 1994 Jun;92(1-3):293-303. doi: 10.1016/0009-2797(94)90071-x.
Eisenhofer G, Coughtrie MW, Goldstein DS. Dopamine sulphate: an enigma resolved. Clin Exp Pharmacol Physiol Suppl. 1999 Apr;26:S41-53.
Swann J, Murry J, Young JA. Cytosolic sulfotransferase 1A1 regulates HIV-1 minus-strand DNA elongation in primary human monocyte-derived macrophages. Virol J. 2016 Feb 24;13:30. doi: 10.1186/s12985-016-0491-9.
Yalcin EB, More V, Neira KL, Lu ZJ, Cherrington NJ, Slitt AL, King RS. Downregulation of sulfotransferase expression and activity in diseased human livers. Drug Metab Dispos. 2013 Sep;41(9):1642-50. doi: 10.1124/dmd.113.050930. Epub 2013 Jun 17.
Wang T, Cook I, Leyh TS. The NSAID allosteric site of human cytosolic sulfotransferases. J Biol Chem. 2017 Dec 8;292(49):20305-20312. doi: 10.1074/jbc.M117.817387. Epub 2017 Oct 16.
Riches Z, Stanley EL, Bloomer JC, Coughtrie MW. Quantitative evaluation of the expression and activity of five major sulfotransferases (SULTs) in human tissues: the SULT "pie". Drug Metab Dispos. 2009 Nov;37(11):2255-61. doi: 10.1124/dmd.109.028399. Epub 2009 Aug 13.
Nagar S, Walther S, Blanchard RL. Sulfotransferase (SULT) 1A1 polymorphic variants *1, *2, and *3 are associated with altered enzymatic activity, cellular phenotype, and protein degradation. Mol Pharmacol. 2006 Jun;69(6):2084-92. doi: 10.1124/mol.105.019240. Epub 2006 Mar 3.
Falany CN, Vazquez ME, Kalb JM. Purification and characterization of human liver dehydroepiandrosterone sulphotransferase. Biochem J. 1989 Jun 15;260(3):641-6. doi: 10.1042/bj2600641.
Cook I, Wang T, Falany CN, Leyh TS. The allosteric binding sites of sulfotransferase 1A1. Drug Metab Dispos. 2015 Mar;43(3):418-23. doi: 10.1124/dmd.114.061887. Epub 2014 Dec 22.
Vietri M, De Santi C, Pietrabissa A, Mosca F, Pacifici GM. Inhibition of human liver phenol sulfotransferase by nonsteroidal anti-inflammatory drugs. Eur J Clin Pharmacol. 2000 Apr;56(1):81-7. doi: 10.1007/s002280050725.
Other Identifiers
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2017-8685
Identifier Type: -
Identifier Source: org_study_id
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