NCT04696393

A Study to Compare the Pharmacokinetics and Safety of Mitapivat 100 mg Tablet Formulation With Mitapivat 2 × 50 mg Tablet Formulation in Healthy Adult Participants

A Phase 1, Open-Label, Randomized, Two-Period, Crossover Study to Compare the Pharmacokinetics and Safety of Mitapivat 100 mg Tablet Formulation With Mitapivat 2 × 50 mg Tablet Formulation in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to characterize and compare the pharmacokinetic profiles of mitapivat following a single dose administration of 100 mg mitapivat in two tablet formulations (50 mg and 100 mg tablet strengths) in healthy adult participants.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Mitapivat tablet	Oral tablets

Timeline

• Start date: 2021-01-06
• Primary completion: 2021-03-19
• Completion: 2021-03-19
• First posted: 2021-01-06
• Last updated: 2021-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study