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NCT03960502 · ClinicalTrials.gov registry record · Phase 1

A Safety and Pharmacokinetic Study of AG-881 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C] AG-881 and Concomitant Intravenous Microdose of [13C315N3] AG-881

A Phase 1 study, sponsored by Agios Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
5
Enrollment target

NCT03960502 is a Phase 1 study that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 5 participants.

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The verdict

NCT03960502, a Phase 1 study, has completed, sponsored by Agios Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

The purpose of this Phase I, open-label study is to evaluate the absorption, distribution, metabolism, excretion, absolute bioavailability, and to characterize the metabolites of AG-881 in healthy male participants following administration of a single oral dose of \[14C\] AG-881 and a concomitant intravenous microdose of \[13C315N3\] AG-881.

Interventions

  • DRUG AG-881
  • DRUG [13C315N3]AG-881

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2019-05-16
Est. Completion 2019-09-07
Phase Phase 1

Sponsor

Agios Pharmaceuticals

44 total trials

What the Registry Record Tells You About NCT03960502

The ClinicalTrials.gov registry entry for NCT03960502 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agios Pharmaceuticals, which has 44 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which AG-881 is the first listed.

NCT03960502 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03960502 about?

NCT03960502 is a clinical study titled "A Safety and Pharmacokinetic Study of AG-881 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C] AG-881 and Concomitant Intravenous Microdose of [13C315N3] AG-881". The purpose of this Phase I, open-label study is to evaluate the absorption, distribution, metabolism, excretion, absolute bioavailability, and to characterize the metabolites of AG-881 in healthy male participants following administration of a single oral dose of \[14C\] AG-881 and a concomitant in...

What is the current status of trial NCT03960502?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2019-05-16. Estimated completion is 2019-09-07.

What interventions are being tested in trial NCT03960502?

The interventions under investigation include: AG-881 (DRUG), [13C315N3]AG-881 (DRUG).

Who is sponsoring clinical trial NCT03960502?

This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.