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Healthy VolunteersPhase 1NCT04565678

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 testing Mitapivat tablets and Mitapivat coated granules in people with Healthy Volunteers, run by Agios Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Mitapivat tablets and Mitapivat coated granules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
21 Sep 2020to 3 Dec 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2), inclusive;
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations;
  • Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception;
  • Participant has no clinically significant history or presence of ECG findings as judged by the Investigator at Screening and Check-in.

Who cannot join

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator;
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, including the 2 soft foods administered in this study, or other substance, unless approved by the Investigator;
  • History of stomach or intestinal surgery or resection including cholecystectomy that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed);
  • History of any malignancy with the exception of non-melanomatous skin cancer in situ, cervical carcinoma in situ, or breast carcinoma in situ;
  • Participant has liver function tests including alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, and total bilirubin that are greater than the upper limit of normal at Screening or Check-in;
  • Participant has platelet count or hemoglobin and hematocrit values that are below the lower limit of normal at Screening or Check-in;
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  • Confirmed (eg, original value and 2 consecutive repeat measurements) systolic blood pressure >150 or <90 millimeters of mercury (mmHg), diastolic blood pressure >90 or <50 mmHg, and pulse rate >100 or <45 beats per minute (bpm);
  • Confirmed QT interval corrected for heart rate using Fridericia's method (QTcF) >450 milliseconds (msec) (male participants) or >470 msec (female participants);
  • History of active alcoholism or drug/chemical abuse within 2 years prior to Check-in;
  • Alcohol consumption of >21 units per week for males and >14 units for females;
  • Positive urine drug screen at Screening or positive alcohol breath test result or positive urine drug screen at Check-in;
  • Positive hepatitis panel and/or positive human immunodeficiency virus test;
  • Participants with an active infection requiring systemic antimicrobial therapy, or with an active infection deemed clinically significant by the Investigator during Screening;
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to dosing (whichever is longer);
  • Participant has used any over-the-counter medications, including herbal or nutritional supplements, within 28 days (or 5 half-lives, whichever is longer) before the first dose of study drug until after the Follow up phone call;
  • Participant has used any prescription (excluding hormone replacement therapy and hormonal birth control) medications within 30 days (or 5 half-lives, whichever is longer) before the first dose of study drug until after the Follow up phone call;
  • Use of tobacco- or nicotine-containing products including cigarettes, snuff, nicotine patch, nicotine chewing gum, vaporizers, or inhalers, within 6 months prior to Screening until after the Follow up phone call, or positive cotinine at Screening or Check-in;
  • Participant must refrain from marijuana or cannabinol-containing products for 7 days before Screening until after the Follow up phone call;
  • Ingestion of poppy seed within 7 days prior to Check-in until after the Follow up phone call;
  • Participant has consumed grapefruit or grapefruit juice, Seville orange, or Seville orange containing products (eg, marmalade) within 7 days before the first dose of study drug until after the Follow up phone call;
  • Participant has consumed caffeine- or xanthine-containing products within 24 hours prior to first dose of study drug until after the Follow up phone call;
  • Participant has consumed vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard), or charbroiled meats for 7 days prior to first dose of study drug until after the Follow-up phone call;
  • Participant is involved in strenuous activity or contact sports from 7 days before Check-in until after the Follow-up phone call;
  • Receipt of blood products within 2 months prior to Check-in;
  • Participant has donated blood or blood products >450 milliliters (mL) within 30 days before the first dose of study drug;
  • Participant has a poor peripheral venous access;
  • Have previously completed or withdrawn from this study or any other study investigating mitapivat sulfate, and have previously received the mitapivat sulfate;
  • Participant has a history of allergy to sulfonamides (eg, co-trimoxazole antibiotic, silver sulfadiazine topical antibiotic for burn wounds) that has been characterized by acute hemolytic anemia, drug-induced liver injury, anaphylaxis, rash of erythema multiforme type, or Stevens-Johnson syndrome.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Unit Inc.

    Dallas, Texas, 75247

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized 4-period Crossover Study to Assess the Relative Bioavailability and Effect of Food on the Coated Granule Formulation of Mitapivat in Healthy Subjects

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.

Being tested
Mitapivat tablets, Mitapivat coated granules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitapivat tabletsDrug

    Also called AG-348, AG-348 sulfate hydrate, Mitapivat sulfate

    Oral tablets

  • Mitapivat coated granulesDrug

    Also called AG-348, AG-348 sulfate hydrate, Mitapivat sulfate

    Oral coated granules

Study groups in NCT04565678
Study groupRoleWhat they receive
Treatment Sequence 1: ABCDExperimentalParticipants will receive Treatment A (mitapivat tablet, orally, under fasted conditions once on Day 1 of Period 1) followed by Treatment B (mitapivat coated granules, orally, under fasted conditions once on Day 1 of Period 2) followed by Treatment C (mitapivat coated granules, with a strawberry yogurt, orally once on Day 1 of Period 3) followed by Treatment D (mitapivat coated granules, with a chocolate pudding, orally once on Day 1 of Period 4). Each Treatment Period will be separated by a Washout Period of 7 days.
Receives: Drug: Mitapivat tablets; Drug: Mitapivat coated granules
Treatment Sequence 2: BDACExperimentalParticipants will receive Treatment B (mitapivat coated granules, orally, under fasted conditions once on Day 1 of Period 1) followed by Treatment D (mitapivat coated granules, with a chocolate pudding, orally once on Day 1 of Period 2) followed by Treatment A (mitapivat tablet, orally, under fasted conditions once on Day 1 of Period 3) followed by Treatment C (mitapivat coated granules, with a strawberry yogurt, orally once on Day 1 of Period 4). Each Treatment Period will be separated by a Washout Period of 7 days.
Receives: Drug: Mitapivat tablets; Drug: Mitapivat coated granules
Treatment Sequence 3: CADBExperimentalParticipants will receive Treatment C (mitapivat coated granules, with a strawberry yogurt, orally once on Day 1 of Period 1) followed by Treatment A (mitapivat tablet, orally, under fasted conditions once on Day 1 of Period 2) followed by Treatment D (mitapivat coated granules, with a chocolate pudding, orally once on Day 1 of Period 3) followed by Treatment B (mitapivat coated granules, orally, under fasted conditions once on Day 1 of Period 4). Each Treatment Period will be separated by a Washout Period of 7 days.
Receives: Drug: Mitapivat tablets; Drug: Mitapivat coated granules
Treatment Sequence 4: DCBAExperimentalParticipants will receive Treatment D (mitapivat coated granules, with a chocolate pudding, orally once on Day 1 of Period 1) followed by Treatment C (mitapivat coated granules, with a strawberry yogurt, orally once on Day 1 of Period 2) followed by Treatment B (mitapivat coated granules, orally, under fasted conditions once on Day 1 of Period 3) followed by Treatment A (mitapivat tablet, orally, under fasted conditions once on Day 1 of Period 4). Each Treatment Period will be separated by a Washout Period of 7 days.
Receives: Drug: Mitapivat tablets; Drug: Mitapivat coated granules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Concentration (Cmax) of Mitapivat Under Fasted Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  2. Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-t) of Mitapivat Under Fasted Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  3. Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of Mitapivat Under Fasted Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  4. Time to Reach Maximum Observed Concentration (Tmax) of Mitapivat Under Fasted Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

Secondary outcomes (16)

  1. Cmax of Mitapivat Under Fed Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  2. AUC0-t of Mitapivat Under Fed Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  3. AUC0-∞ of Mitapivat Under Fed Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  4. Tmax of Mitapivat Under Fed Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  5. Relative Bioavailability (Frel) Under Fasted and Fed Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  6. Area Under the Plasma Concentration-Time Curve from Time Zero to Twelve Hours (AUC0-12) of Mitapivat Under Fasted and Fed Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  7. Apparent Plasma Terminal Elimination Half-life (t½) of Mitapivat Under Fasted and Fed Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  8. Apparent Total Plasma Clearance (CL/F) of Mitapivat Under Fasted and Fed Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  9. Apparent Volume of Distribution (Vz/F) of Mitapivat Under Fasted and Fed Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  10. Apparent Terminal Elimination Rate Constant (λz) of Mitapivat Under Fasted and Fed Conditions

    Measured: Pre-dose and multiple time points post-dose (up to 72 hours)

  11. Number of Participants With Adverse Event (AEs)

    Measured: Up to approximately 9 weeks

  12. Number of Participants With AEs, Graded by Severity

    Measured: Up to approximately 9 weeks

  13. Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values

    Measured: Up to approximately 9 weeks

  14. Number of Participants With Clinically Significant Abnormal Findings for 12-lead Electrocardiogram (ECG) Parameters

    Measured: Up to approximately 9 weeks

  15. Number of Participants With Clinically Significant Abnormal Findings for Vital Signs Parameters

    Measured: Up to approximately 9 weeks

  16. Number of Participants With Clinically Significant Abnormal Physical Examination Findings

    Measured: Up to approximately 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start21 Sep 2020
  3. Primary completion3 Dec 2020
  4. Study completion3 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04565678
Sponsor's protocol ID
AG348-C-019
Status last verified
Dec 2020
First submitted
22 Sep 2020
Last updated
10 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mitapivat tablets and Mitapivat coated granules in people with Healthy Volunteers, run by Agios Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Concentration (Cmax) of Mitapivat Under Fasted Conditions (time frame: Pre-dose and multiple time points post-dose (up to 72 hours)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04565678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.

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