MedTrace Logo

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

NCT03960502 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-10-23

No results posted yet for this 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.

Conditions

  • Healthy Male Participants

Interventions

DRUG

AG-881

Single oral dose of approximately 50 mg AG-881 (free form) containing approximately 100 microcuries (μCi) of \[14C\]AG-881.

DRUG

[13C315N3]AG-881

Single IV microdose of approximately 100 μg.

Sponsors & Collaborators

  • Agios Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Affairs · Agios Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2019-09-07
Completion
2019-09-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03960502 on ClinicalTrials.gov