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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: Completed Phase 1 study of Moderate Hepatic Impairment, sponsored by Agios Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT05610657 record still lists
NCT05610657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, roughly in line with the 21-participant average among 4 other Moderate Hepatic Impairment trials with a reported enrollment target.
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 a single indexed study location in 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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