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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT03250598

Public ClinicalTrials.gov record NCT03250598. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:00 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Single-Dose, Open-Label Study to Characterize and Compare the Pharmacokinetics, Safety, and Effect on QTc Interval of AG-348 in Healthy Subjects of Japanese Origin and Healthy Subjects of Non-Asian Origin

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03250598
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Enrollment
60 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 8, 2017
Primary completion
Oct 1, 2017
Completion
Oct 8, 2017
Last update posted
Oct 18, 2017

2017

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
West Coast Clinical Trial (WCCT) Global, Inc. Cypress California 90630

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03250598, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 18, 2017 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03250598 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →