Studies of Sulfur Metabolism in Humans

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

January 11, 2018

Primary Completion Date

February 2, 2023

Study Completion Date

February 2, 2023

Conditions
Metabolic Side Effects of Drugs
Interventions
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.

Trial Locations (1)

10461

Albert Einstein Collage of Medicine, The Bronx

All Listed Sponsors
lead

Albert Einstein College of Medicine

OTHER

NCT03383133 - Studies of Sulfur Metabolism in Humans | Biotech Hunter | Biotech Hunter