<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04472832</url>
  </required_header>
  <id_info>
    <org_study_id>AG348-C-014</org_study_id>
    <nct_id>NCT04472832</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants</brief_title>
  <official_title>A Phase 1, Randomized, Four-Period, Crossover Food-Effect Study With Mitapivat Sulfate In Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Agios Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Agios Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1, randomized, single-dose, double-blinded, 4-period, crossover study to&#xD;
      evaluate the pharmacokinetics, safety, and tolerability of mitapivat in healthy adult&#xD;
      participants under fasted and fed (high-fat meal) conditions. Secondary objectives include&#xD;
      evaluating the effect of mitapivat on electrocardiogram (ECG) parameters, including&#xD;
      concentration-QT interval corrected for heart rate (C-QTc) analysis under fasted conditions.&#xD;
      The study will include a 28-day screening period, four 7-day treatment periods. Participants&#xD;
      will receive a follow-up telephone call within 28 (±1) days after the last dose of study&#xD;
      drug.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Actual">November 23, 2020</completion_date>
  <primary_completion_date type="Actual">November 23, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-T) for Mitapivat Under Fasted and High-Fat Meal Conditions</measure>
    <time_frame>Predose and at various timepoints through 120 hours postdose within each 7-day period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC From Time 0 Extrapolated to Infinity (AUC0-Inf) for Mitapivat Under Fasted and High-Fat Meal Conditions</measure>
    <time_frame>Predose and at various timepoints through 120 hours postdose within each 7-day period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) for Mitapivat Under Fasted and High-Fat Meal Conditions</measure>
    <time_frame>Predose and at various timepoints through 120 hours postdose within each 7-day period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) for Mitapivat Under Fasted and High-Fat Meal Conditions</measure>
    <time_frame>Predose and at various timepoints through 120 hours postdose within each 7-day period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Half-Life (T1/2) for Mitapivat Under Fasted and High-Fat Meal Conditions</measure>
    <time_frame>Predose and at various timepoints through 120 hours postdose within each 7-day period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Oral Clearance (CL/F) for Mitapivat Under Fasted and High-Fat Meal Conditions</measure>
    <time_frame>Predose and at various timepoints through 120 hours postdose within each 7-day period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Rate Constant (Λz) for Mitapivat Under Fasted and High-Fat Meal Conditions</measure>
    <time_frame>Predose and at various timepoints through 120 hours postdose within each 7-day period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Volume of Distribution (Vd/F) for Mitapivat Under Fasted and High-Fat Meal Conditions</measure>
    <time_frame>Predose and at various timepoints through 120 hours postdose within each 7-day period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Bioavailability (Frel; AUC0-Inf [fed]/AUC0-Inf [fasted]) for Fed Treatment Following Administration of Mitapivat 100-mg Dose</measure>
    <time_frame>Predose and at various timepoints through 120 hours postdose within each 7-day period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs)</measure>
    <time_frame>Up to approximately 8 weeks</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Abnormalities in Clinical Laboratory Findings</measure>
    <time_frame>Up to approximately 8 weeks</time_frame>
    <description>Clinical laboratory tests will include hematology, serum chemistry, and urinalysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Abnormalities in Vital Sign Measurements</measure>
    <time_frame>Up to approximately 8 weeks</time_frame>
    <description>Vital sign measurements will include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Abnormalities in 12-lead Electrocardiogram (ECG) Results</measure>
    <time_frame>Up to approximately 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Abnormalities in Physical Examination Findings</measure>
    <time_frame>Up to approximately 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive a single oral dose of mitapivat-matching placebo under fasted conditions on Day 1 of each of 4 periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral dose of mitapivat 100 milligrams (mg) and placebo under fasted conditions on Day 1 of each of 4 periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral dose of mitapivat 100 mg and placebo under high-fat meal conditions on Day 1 of each of 4 periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral dose of mitapivat 300 mg under fasted conditions on Day 1 of each of 4 periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Treatment A</intervention_name>
    <description>6 tablets matched to mitapivat tablet</description>
    <arm_group_label>Treatment A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mitapivat 100 mg</intervention_name>
    <description>Two 50-mg tablets</description>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_label>Treatment C</arm_group_label>
    <other_name>AG-348</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Treatment B</intervention_name>
    <description>4 tablets matched to mitapivat tablet</description>
    <arm_group_label>Treatment B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mitapivat 300 mg</intervention_name>
    <description>Six 50-mg tablets</description>
    <arm_group_label>Treatment D</arm_group_label>
    <other_name>AG-348</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Treatment C</intervention_name>
    <description>4 tablets matched to mitapivat tablet</description>
    <arm_group_label>Treatment C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is male or female 18 to 55 years of age, inclusive;&#xD;
&#xD;
          -  If female, is not currently pregnant or breastfeeding OR is of non-childbearing&#xD;
             potential, defined as either:&#xD;
&#xD;
               -  Being clinically infertile as the result of surgical sterilization, confirmed&#xD;
                  postmenopausal status, or another documented medical condition (eg, was born&#xD;
                  without a uterus) OR&#xD;
&#xD;
               -  Agreeing to either abstain from sexual intercourse with a male partner OR agrees&#xD;
                  to use a highly effective form of contraception, beginning at the time of&#xD;
                  screening and continuing throughout the study and for 28 days after dosing. The&#xD;
                  following are considered highly effective forms of contraception: hormonal oral&#xD;
                  contraceptives, injectables, and patches; intrauterine devices; double-barrier&#xD;
                  methods (synthetic condom, diaphragm, or cervical cap used with spermicidal foam,&#xD;
                  cream, or gel); and male partner sterilization;&#xD;
&#xD;
          -  If male, agrees to abstain from sexual intercourse with a female partner OR agrees to&#xD;
             use a highly effective form of contraception, beginning at the time of screening and&#xD;
             continuing throughout the study and for 90 days after dosing, AND to refrain from&#xD;
             donating sperm for the duration of the study and for 90 days after dosing;&#xD;
&#xD;
          -  Participant has a body mass index 18 to 32 kilograms per square meter (kg/m^2),&#xD;
             inclusive, at screening;&#xD;
&#xD;
          -  Participant is considered by the investigator to be in good general health as&#xD;
             determined by medical history, clinical laboratory test results, vital sign&#xD;
             measurements, 12-lead ECG results, and physical examination findings at screening;&#xD;
&#xD;
          -  Participant has no clinically significant history or presence of ECG findings as&#xD;
             judged by the investigator at screening and check-in, including each criterion as&#xD;
             follows:&#xD;
&#xD;
               -  Normal sinus rhythm (heart rate [HR] between 45 beats per minute [bpm] and 100&#xD;
                  bpm inclusive);&#xD;
&#xD;
               -  QT interval corrected for HR using Fridericia's formula (QTcF) ≤450 milliseconds&#xD;
                  (msec);&#xD;
&#xD;
               -  QRS interval ≤110 msec; and confirmed by manual over read if &gt;110 msec;&#xD;
&#xD;
               -  PR interval between 120 and 220 msec;&#xD;
&#xD;
          -  Participant agrees to comply with all protocol requirements;&#xD;
&#xD;
          -  Participant is able to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has any medical or surgical condition that, in the opinion of the&#xD;
             investigator, could affect study drug absorption, distribution, metabolism, or&#xD;
             excretion;&#xD;
&#xD;
          -  Participant has undergone any major surgical procedure within the 3 months prior to&#xD;
             screening;&#xD;
&#xD;
          -  Participant has a history of any primary malignancy (including any melanoma or&#xD;
             suspicious undiagnosed skin lesions), with the exception of in situ basal cell or&#xD;
             squamous cell carcinomas of the skin, cervical carcinoma in situ, or other&#xD;
             malignancies that have been curatively treated and for which the participant has&#xD;
             displayed no evidence of disease within the 5 years prior to screening;&#xD;
&#xD;
          -  Participant has glucose-6-phosphate-dehydrogenase deficiency;&#xD;
&#xD;
          -  Participant has a known history or presence of liver disease.&#xD;
&#xD;
          -  Participant has a positive test result for hepatitis B surface antigen (HBsAg),&#xD;
             hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV) types 1 or 2&#xD;
             antibodies at screening;&#xD;
&#xD;
          -  Participant has liver function tests including alanine aminotransferase (ALT),&#xD;
             aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin that are&#xD;
             greater than the upper limit of normal at screening or check-in (results may be&#xD;
             repeated once);&#xD;
&#xD;
          -  Participant has platelet count or hemoglobin and hematocrit values that are below the&#xD;
             lower limit of normal at screening or check-in (results may be repeated once);&#xD;
&#xD;
          -  Participant has a positive test result for drugs of abuse, alcohol, or cotinine&#xD;
             (indicating active current smoking) at screening or before the first dose of study&#xD;
             drug or throughout the study.&#xD;
&#xD;
          -  Participant has used any prescription (excluding hormonal birth control) medications&#xD;
             within 30 days (or 5 half-lives, whichever is longer) before the first dose of study&#xD;
             drug or throughout the study;&#xD;
&#xD;
          -  Participant has used any over-the-counter medications, including herbal or nutritional&#xD;
             supplements, within 28 days (or 5 half-lives, whichever is longer) before the first&#xD;
             dose of study drug or throughout the study;&#xD;
&#xD;
          -  Participant has received study drug in another investigational study within 30 days&#xD;
             (or 5 half-lives, whichever is longer) of dosing.&#xD;
&#xD;
          -  Participant has donated blood or blood products &gt;450 milliliters (mL) within 30 days&#xD;
             before the first dose of study drug.&#xD;
&#xD;
          -  Participant has history or presence of:&#xD;
&#xD;
               -  Risk factors for torsades de pointes (eg, heart failure, cardiomyopathy, or&#xD;
                  family history of long QT syndrome);&#xD;
&#xD;
               -  Sick sinus syndrome, second- or third-degree atrioventricular block, myocardial&#xD;
                  infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or&#xD;
                  conduction abnormalities;&#xD;
&#xD;
               -  Repeated or frequent syncope or vasovagal episodes;&#xD;
&#xD;
               -  Hypertension, angina, bradycardia (if assessed as clinically significant by the&#xD;
                  investigator), or severe peripheral arterial circulatory disorders;&#xD;
&#xD;
               -  Clinically significant laboratory assessment findings, including hypokalemia,&#xD;
                  hypercalcemia, or hypomagnesemia;&#xD;
&#xD;
          -  Participant has history or presence of:&#xD;
&#xD;
               -  Any evidence of atrial fibrillation, atrial flutter, complete right or left&#xD;
                  bundle branch block, or Wolff-Parkinson-White syndrome on the screening or&#xD;
                  baseline ECG;&#xD;
&#xD;
               -  Any morphology that renders measurement of QT interval imprecise (eg,&#xD;
                  neuromuscular artifact that cannot be readily eliminated, indistinct QRS onset,&#xD;
                  low-amplitude T-wave, merged T and U-waves, prominent U-waves, arrhythmia) on the&#xD;
                  screening or baseline ECG.&#xD;
&#xD;
          -  Participant is not willing to refrain from marijuana or cannabinol-containing products&#xD;
             for 7 days before the first dose of study drug and throughout the study;&#xD;
&#xD;
          -  Participant has consumed caffeine- or xanthine containing products within 24 hours&#xD;
             prior to first dose of study drug or throughout the study;&#xD;
&#xD;
          -  Participant has consumed grapefruit or grapefruit juice, Seville orange or Seville&#xD;
             orange containing products (eg, marmalade) within 28 days before the first dose of&#xD;
             study drug or throughout the study;&#xD;
&#xD;
          -  Participant has consumed fruit juices 72 hours prior to first dosing or during the&#xD;
             study (with exception to the juices in relation to the fruits specified above);&#xD;
&#xD;
          -  Participant has consumed vegetables from the mustard green family (eg, kale, broccoli,&#xD;
             watercress, collard greens, kohlrabi, Brussel sprouts, and mustard), or charbroiled&#xD;
             meats for 7 days prior to first dose of study drug or throughout the study;&#xD;
&#xD;
          -  Participant is a smoker or has used nicotine or nicotine-containing products (eg,&#xD;
             snuff, nicotine patch, nicotine chewing gum, mock cigarettes, vaporizers, or inhalers)&#xD;
             within 6 months before the first dose of study drug;&#xD;
&#xD;
          -  Participant has a history of alcohol abuse or drug addiction within the last year or&#xD;
             excessive alcohol consumption (regular alcohol intake &gt;21 units per week for male&#xD;
             participants and &gt;14 units of alcohol per week for female participants) (1 unit is&#xD;
             equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1&#xD;
             measure [25 mL] of spirits) or consumed alcohol 72 hours before the first dose of&#xD;
             study drug or throughout the follow-up telephone call;&#xD;
&#xD;
          -  Participant is involved in strenuous activity or contact sports within 24 hours before&#xD;
             the first dose of study drug or throughout the study;&#xD;
&#xD;
          -  Participant has a history of relevant drug and/or food allergies (ie, allergy to&#xD;
             mitapivat or excipients [microcrystalline cellulose, croscarmellose sodium, sodium&#xD;
             stearyl fumarate, magnesium stearate, and mannitol]);&#xD;
&#xD;
          -  Participant has a history of allergy to sulfonamides (eg, co-trimoxazole antibiotic,&#xD;
             silver sulfadiazine topical antibiotic for burn wounds) that has been characterized by&#xD;
             acute hemolytic anemia, drug-induced liver injury, anaphylaxis, rash of erythema&#xD;
             multiforme type, or Stevens-Johnson syndrome;&#xD;
&#xD;
          -  In the opinion of the investigator, the participant is not suitable for entry into the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Affairs</last_name>
    <role>Study Chair</role>
    <affiliation>Agios Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PPD Development, LP</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitapivat</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04472832
org study id: AG348-C-014
nct id: NCT04472832
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, randomized, single-dose, double-blinded, 4-period, crossover study to
      evaluate the pharmacokinetics, safety, and tolerability of mitapivat in healthy adult
      participants under fasted and fed (high-fat meal) conditions. Secondary objectives include
      evaluating the effect of mitapivat on electrocardiogram (ECG) parameters, including
      concentration-QT interval corrected for heart rate (C-QTc) analysis under fasted conditions.
      The study will include a 28-day screening period, four 7-day treatment periods. Participants
      will receive a follow-up telephone call within 28 (±1) days after the last dose of study
      drug.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-T) for Mitapivat Under Fasted and High-Fat Meal Conditions
time frame: Predose and at various timepoints through 120 hours postdose within each 7-day period
measure: AUC From Time 0 Extrapolated to Infinity (AUC0-Inf) for Mitapivat Under Fasted and High-Fat Meal Conditions
time frame: Predose and at various timepoints through 120 hours postdose within each 7-day period
measure: Maximum Observed Plasma Concentration (Cmax) for Mitapivat Under Fasted and High-Fat Meal Conditions
time frame: Predose and at various timepoints through 120 hours postdose within each 7-day period
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for Mitapivat Under Fasted and High-Fat Meal Conditions
time frame: Predose and at various timepoints through 120 hours postdose within each 7-day period
measure: Apparent Terminal Elimination Half-Life (T1/2) for Mitapivat Under Fasted and High-Fat Meal Conditions
time frame: Predose and at various timepoints through 120 hours postdose within each 7-day period
measure: Apparent Oral Clearance (CL/F) for Mitapivat Under Fasted and High-Fat Meal Conditions
time frame: Predose and at various timepoints through 120 hours postdose within each 7-day period
measure: Apparent Terminal Elimination Rate Constant (Λz) for Mitapivat Under Fasted and High-Fat Meal Conditions
time frame: Predose and at various timepoints through 120 hours postdose within each 7-day period
measure: Apparent Volume of Distribution (Vd/F) for Mitapivat Under Fasted and High-Fat Meal Conditions
time frame: Predose and at various timepoints through 120 hours postdose within each 7-day period
measure: Relative Bioavailability (Frel; AUC0-Inf [fed]/AUC0-Inf [fasted]) for Fed Treatment Following Administration of Mitapivat 100-mg Dose
time frame: Predose and at various timepoints through 120 hours postdose within each 7-day period
measure: Percentage of Participants With Adverse Events (AEs)
time frame: Up to approximately 8 weeks
description: An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.
measure: Percentage of Participants with Abnormalities in Clinical Laboratory Findings
time frame: Up to approximately 8 weeks
description: Clinical laboratory tests will include hematology, serum chemistry, and urinalysis.
measure: Percentage of Participants With Abnormalities in Vital Sign Measurements
time frame: Up to approximately 8 weeks
description: Vital sign measurements will include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.
measure: Percentage of Participants With Abnormalities in 12-lead Electrocardiogram (ECG) Results
time frame: Up to approximately 8 weeks
measure: Percentage of Participants With Abnormalities in Physical Examination Findings
time frame: Up to approximately 8 weeks
arm group label: Treatment A
arm group type: Placebo Comparator
description: Participants will receive a single oral dose of mitapivat-matching placebo under fasted conditions on Day 1 of each of 4 periods.
arm group label: Treatment B
arm group type: Experimental
description: Participants will receive a single oral dose of mitapivat 100 milligrams (mg) and placebo under fasted conditions on Day 1 of each of 4 periods.
arm group label: Treatment C
arm group type: Experimental
description: Participants will receive a single oral dose of mitapivat 100 mg and placebo under high-fat meal conditions on Day 1 of each of 4 periods.
arm group label: Treatment D
arm group type: Experimental
description: Participants will receive a single oral dose of mitapivat 300 mg under fasted conditions on Day 1 of each of 4 periods.
intervention type: Drug
intervention name: Placebo for Treatment A
description: 6 tablets matched to mitapivat tablet
arm group label: Treatment A
intervention type: Drug
intervention name: Mitapivat 100 mg
description: Two 50-mg tablets
arm group label: Treatment B
arm group label: Treatment C
other name: AG-348
intervention type: Drug
intervention name: Placebo for Treatment B
description: 4 tablets matched to mitapivat tablet
arm group label: Treatment B
intervention type: Drug
intervention name: Mitapivat 300 mg
description: Six 50-mg tablets
arm group label: Treatment D
other name: AG-348
intervention type: Drug
intervention name: Placebo for Treatment C
description: 4 tablets matched to mitapivat tablet
arm group label: Treatment C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Affairs
role: Study Chair
affiliation: Agios Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mitapivat
sharing ipd: No