NCT05610657

A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function

A Phase 1, Open-label, Single-dose, Pharmacokinetic Study of Mitapivat in Subjects With Moderate Hepatic Impairment Compared to Matched Healthy Control Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Agios Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to compare the pharmacokinetics (PK) of a single oral dose of mitapivat in participants with moderate hepatic impairment to that in matched healthy control participants with normal hepatic function.

Conditions

• Moderate Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Mitapivat	Mitapivat tablets

Timeline

• Start date: 2023-01-10
• Primary completion: 2023-07-21
• Completion: 2023-07-21
• First posted: 2022-11-09
• Last updated: 2023-09-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study