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NCT05610657 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function
A Phase 1 study of Moderate Hepatic Impairment, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 3
- Study locations
NCT05610657 is a Phase 1 study of Moderate Hepatic Impairment that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 20 participants, roughly in line with the 21-participant average among 4 other Moderate Hepatic Impairment trials with a reported enrollment target. The trial reports 3 study locations across 2 states.
The verdict
NCT05610657, a Phase 1 study of Moderate Hepatic Impairment, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 3
- Study locations
Study 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 Studied
Interventions
- DRUG Mitapivat
Study Locations (3)
Florida
- Clinical Pharmacology of Miami (CPMI) - Miami
- Orlando Clinical Research Center (OCRC) - Orlando
California
- Orange County Research Center (OCRC) - Tustin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2023-07-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05610657
The ClinicalTrials.gov registry entry for NCT05610657 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 21-participant average among 4 other Moderate Hepatic Impairment trials with a reported enrollment target. The listed sponsor is Agios Pharmaceuticals, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Moderate Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Mitapivat is the first listed.
NCT05610657 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Florida, California.
Frequently Asked Questions
What is clinical trial NCT05610657 about?
NCT05610657 is a clinical study titled "A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function". 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.
What is the current status of trial NCT05610657?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-01-10. Estimated completion is 2023-07-21.
What conditions does trial NCT05610657 study?
This clinical trial studies the following conditions: Moderate Hepatic Impairment.
What interventions are being tested in trial NCT05610657?
The interventions under investigation include: Mitapivat (DRUG).
Who is sponsoring clinical trial NCT05610657?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05610657 being conducted?
This trial has 3 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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