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Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin

NCT03250598 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-10-19

No results posted yet for this study

Summary

The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in Japanese and Non-Asian subjects. Pharmacokinetic sampling will take place serially at specified times during conduct of the study.

Conditions

  • Healthy
  • Japanese
  • Non-Asian

Interventions

DRUG

AG-348

50 mg single-dose

DRUG

AG-348

5 mg single-dose

DRUG

AG-348

200 mg single-dose

Sponsors & Collaborators

  • Agios Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Affairs Agios Pharmaceuticals, Inc · Agios Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-08-09
Primary Completion
2017-10-02
Completion
2017-10-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03250598 on ClinicalTrials.gov