Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04565678 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Relative Bioavailability and Effect of Food on the Coated Granule Formulation of Mitapivat in Healthy Participants
A Phase 1 study of Healthy Volunteers, sponsored by Agios Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT04565678: Completed Phase 1 study of Healthy Volunteers, sponsored by Agios Pharmaceuticals.
NCT04565678 is a Phase 1 study of Healthy Volunteers that has completed, run by Agios Pharmaceuticals. The registered enrollment target is 32 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04565678, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Agios Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this study is to assess the relative bioavailability of the mitapivat coated granule formulation compared to the tablet formulation following a single oral dose of mitapivat under fasted conditions in healthy adult participants.
Conditions Studied
Interventions
- DRUG Mitapivat tablets
- DRUG Mitapivat coated granules
Study Locations (1)
Texas
- Covance Clinical Research Unit Inc. - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2020-12-03 |
| Phase | Phase 1 |
What the finished NCT04565678 record still lists
NCT04565678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Mitapivat tablets is the first listed.
NCT04565678 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04565678 about?
NCT04565678 is a clinical study titled "A Study to Assess the Relative Bioavailability and Effect of Food on the Coated Granule Formulation of Mitapivat in Healthy Participants". The primary purpose of this study is to assess the relative bioavailability of the mitapivat coated granule formulation compared to the tablet formulation following a single oral dose of mitapivat under fasted conditions in healthy adult participants.
What is the current status of trial NCT04565678?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-09-21. Estimated completion is 2020-12-03.
What conditions does trial NCT04565678 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04565678?
The interventions under investigation include: Mitapivat tablets (DRUG), Mitapivat coated granules (DRUG).
Who is sponsoring clinical trial NCT04565678?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04565678 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04565678's enrollment target sits among peer trials
32 171st of 283 higher than 99 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
RECRUITING · Phase 1
-
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
RECRUITING · Phase 1
-
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
RECRUITING · Phase 1
-
Classroom Break, Cognition, and Fitness in Elementary School Children
RECRUITING · Phase 1
-
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02445781 · 32 participants · Early Phase 1
Differing Levels of Hypoglycemia
- NCT02792270 · 32 participants · NA
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
- NCT03068910 · 32 participants · Early Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
- NCT03208868 · 32 participants · NA
Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI