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COMPLETED Phase 1

A Study to Compare the Pharmacokinetics and Safety of Mitapivat 100 mg Tablet Formulation With Mitapivat 2 × 50 mg Tablet Formulation in Healthy Adult Participants

NCT04696393 · View on ClinicalTrials.gov ↗

Study Summary

The primary purpose of this study is to characterize and compare the pharmacokinetic profiles of mitapivat following a single dose administration of 100 mg mitapivat in two tablet formulations (50 mg and 100 mg tablet strengths) in healthy adult participants.

Conditions Studied

Interventions

  • DRUG Mitapivat tablet

Study Locations (1)

Texas

  • PPD Development, LP — Austin

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2021-01-06
Est. Completion 2021-03-19
Phase Phase 1

Sponsor

Agios Pharmaceuticals

15 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04696393

The ClinicalTrials.gov registry entry for NCT04696393 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agios Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention — of which Mitapivat tablet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04696393 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04696393 about?

NCT04696393 is a clinical study titled "A Study to Compare the Pharmacokinetics and Safety of Mitapivat 100 mg Tablet Formulation With Mitapivat 2 × 50 mg Tablet Formulation in Healthy Adult Participants". The primary purpose of this study is to characterize and compare the pharmacokinetic profiles of mitapivat following a single dose administration of 100 mg mitapivat in two tablet formulations (50 mg and 100 mg tablet strengths) in healthy adult participants.

What is the current status of trial NCT04696393?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2021-01-06. Estimated completion is 2021-03-19.

What conditions does trial NCT04696393 study?

This clinical trial studies the following conditions: Healthy Volunteers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04696393?

The interventions under investigation include: Mitapivat tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04696393?

This trial is sponsored by Agios Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04696393 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial