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

Conditions

• Moderate Hepatic Impairment

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Mitapivat — DRUG
  Mitapivat tablets

Study Details

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.

Key Dates

Start date

Jan 10, 2023

Status verified

Sep 2023

Primary completion

Jul 21, 2023

Completion

Jul 21, 2023

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Mitapivat
  Mitapivat tablet as a single oral dose, under fasted conditions on Day 1 to compare participants with normal hepatic function to participants with moderate hepatic function (Child-Pugh \[C-P\] Score B, score of 7 to 9).

Primary Outcome Measure

Area Under the Plasma Concentration-Time Curve From Time 0 (Predose) to Extrapolated to Infinity Time (AUC∞) of Mitapivat [ Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 17 ]

Locations (3)

Find similar trials in Tustin, CA

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