NCT03250598

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	AG-348	50 mg single-dose
DRUG	AG-348	5 mg single-dose
DRUG	AG-348	200 mg single-dose

Timeline

• Start date: 2017-08-09
• Primary completion: 2017-10-02
• Completion: 2017-10-09
• First posted: 2017-08-15
• Last updated: 2017-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study