drugset / Trial / NCT03250598
Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin
Non-randomizedSequentialOpen-labelOther
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.
Timeline
- Start
- 2017-08-09
- Primary completion
- 2017-10-02
- Completion
- 2017-10-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitapivat | Small molecule | 5 mg | Oral |
| Subject | Mitapivat | Small molecule | 50 mg | Oral |
| Subject | Mitapivat | Small molecule | 200 mg | Oral |
Indications
No indication recorded.