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NCT03383133 · ClinicalTrials.gov registry record · Early Phase 1

Studies of Sulfur Metabolism in Humans

A Early Phase 1 study of Metabolic Side Effects of Drugs, sponsored by Albert Einstein College of Medicine.

Completed
Registry status
Early Phase 1
Development phase
1
Enrollment target
1
Study location

NCT03383133: Completed Early Phase 1 study of Metabolic Side Effects of Drugs, sponsored by Albert Einstein College of Medicine.

NCT03383133 is a Early Phase 1 study of Metabolic Side Effects of Drugs that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 1 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03383133, a Early Phase 1 study of Metabolic Side Effects of Drugs, has completed, sponsored by Albert Einstein College of Medicine.

COMPLETED
Registry status
Early Phase 1
Development phase
1 participants
Enrollment target
1
Study location

Study 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).

Primary Outcome

Proton NMR Signals will be used to quantitate conjugates of acetaminophen and dehydroepiandrosterone in urine.

Interventions

  • DRUG SULT Allosteric Inhibition

Study Locations (1)

New York

  • Albert Einstein Collage of Medicine - The Bronx

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2018-01-11
Est. Completion 2023-02-02
Phase Early Phase 1
Albert Einstein College of Medicine

175 total trials

What the finished NCT03383133 record still lists

NCT03383133 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Metabolic Side Effects of Drugs appearing as the primary indexed condition, and to 1 intervention - of which SULT Allosteric Inhibition is the first listed.

NCT03383133 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT03383133 about?

NCT03383133 is a clinical study titled "Studies of Sulfur Metabolism in Humans". 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...

What is the current status of trial NCT03383133?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2018-01-11. Estimated completion is 2023-02-02.

What conditions does trial NCT03383133 study?

This clinical trial studies the following conditions: Metabolic Side Effects of Drugs.

What interventions are being tested in trial NCT03383133?

The interventions under investigation include: SULT Allosteric Inhibition (DRUG).

Who is sponsoring clinical trial NCT03383133?

This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03383133 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03383133's enrollment target sits among peer trials

1 1986th of 2000 the lowest of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03383133, the US trial registry maintained by the National Library of Medicine. NCT03383133 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.