NCT04565678

A Study to Assess the Relative Bioavailability and Effect of Food on the Coated Granule Formulation of Mitapivat in Healthy Participants

A Phase 1, Open-label, Randomized 4-period Crossover Study to Assess the Relative Bioavailability and Effect of Food on the Coated Granule Formulation of Mitapivat in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to assess the relative bioavailability of the mitapivat coated granule formulation compared to the tablet formulation following a single oral dose of mitapivat under fasted conditions in healthy adult participants.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Mitapivat tablets	Oral tablets
DRUG	Mitapivat coated granules	Oral coated granules

Timeline

• Start date: 2020-09-21
• Primary completion: 2020-12-03
• Completion: 2020-12-03
• First posted: 2020-09-25
• Last updated: 2020-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study