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

Part of paid clinical trials in Tustin, California.

Sponsor
Agios Pharmaceuticals, Inc.
Study ID
NCT05610657
Phase
PHASE1
Status
Completed

Conditions

  • Moderate Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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)

FacilityCityStateZIPSite coordinators
Orange County Research Center (OCRC)TustinCalifornia92780-
Clinical Pharmacology of Miami (CPMI)MiamiFlorida33014-
Orlando Clinical Research Center (OCRC)OrlandoFlorida32809-

Find similar trials in Tustin, CA

By research site
Orange County Research Center (OCRC)· Tustin, CAClinical Pharmacology of Miami (CPMI)· Miami, FLOrlando Clinical Research Center (OCRC)· Orlando, FL

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