Healthy VolunteersPhase 1NCT04472832
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants
A Phase 1 study testing Mitapivat 100 mg and Mitapivat 300 mg in people with Healthy Volunteers, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
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. 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 100 mg and Mitapivat 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2020to 23 Nov 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
- Participant is male or female 18 to 55 years of age, inclusive;
- If female, is not currently pregnant or breastfeeding OR is of non-childbearing potential, defined as either:
- Being clinically infertile as the result of surgical sterilization, confirmed postmenopausal status, or another documented medical condition (eg, was born without a uterus) OR
- Agreeing to either abstain from sexual intercourse with a male partner OR agrees to use a highly effective form of contraception, beginning at the time of screening and continuing throughout the study and for 28 days after dosing. The following are considered highly effective forms of contraception: hormonal oral contraceptives, injectables, and patches; intrauterine devices; double-barrier methods (synthetic condom, diaphragm, or cervical cap used with spermicidal foam, cream, or gel); and male partner sterilization;
- If male, agrees to abstain from sexual intercourse with a female partner OR agrees to use a highly effective form of contraception, beginning at the time of screening and continuing throughout the study and for 90 days after dosing, AND to refrain from donating sperm for the duration of the study and for 90 days after dosing;
- Participant has a body mass index 18 to 32 kilograms per square meter (kg/m^2), inclusive, at screening;
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- Participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening;
- Participant has no clinically significant history or presence of ECG findings as judged by the investigator at screening and check-in, including each criterion as follows:
- Normal sinus rhythm (heart rate [HR] between 45 beats per minute [bpm] and 100 bpm inclusive);
- QT interval corrected for HR using Fridericia's formula (QTcF) ≤450 milliseconds (msec);
- QRS interval ≤110 msec; and confirmed by manual over read if >110 msec;
- PR interval between 120 and 220 msec;
- Participant agrees to comply with all protocol requirements;
- Participant is able to provide written informed consent.
Who cannot join
- Participant has any medical or surgical condition that, in the opinion of the investigator, could affect study drug absorption, distribution, metabolism, or excretion;
- Participant has undergone any major surgical procedure within the 3 months prior to screening;
- Participant has a history of any primary malignancy (including any melanoma or suspicious undiagnosed skin lesions), with the exception of in situ basal cell or squamous cell carcinomas of the skin, cervical carcinoma in situ, or other malignancies that have been curatively treated and for which the participant has displayed no evidence of disease within the 5 years prior to screening;
- Participant has glucose-6-phosphate-dehydrogenase deficiency;
- Participant has a known history or presence of liver disease.
- Participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening;
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- Participant has liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin that are greater than the upper limit of normal at screening or check-in (results may be repeated once);
- Participant has platelet count or hemoglobin and hematocrit values that are below the lower limit of normal at screening or check-in (results may be repeated once);
- Participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug or throughout the study.
- Participant has used any prescription (excluding hormonal birth control) medications within 30 days (or 5 half-lives, whichever is longer) before the first dose of study drug or throughout the study;
- 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 or throughout the study;
- Participant has received study drug in another investigational study within 30 days (or 5 half-lives, whichever is longer) of dosing.
- Participant has donated blood or blood products >450 milliliters (mL) within 30 days before the first dose of study drug.
- Participant has history or presence of:
- Risk factors for torsades de pointes (eg, heart failure, cardiomyopathy, or family history of long QT syndrome);
- Sick sinus syndrome, second- or third-degree atrioventricular block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities;
- Repeated or frequent syncope or vasovagal episodes;
- Hypertension, angina, bradycardia (if assessed as clinically significant by the investigator), or severe peripheral arterial circulatory disorders;
- Clinically significant laboratory assessment findings, including hypokalemia, hypercalcemia, or hypomagnesemia;
- Participant has history or presence of:
- Any evidence of atrial fibrillation, atrial flutter, complete right or left bundle branch block, or Wolff-Parkinson-White syndrome on the screening or baseline ECG;
- Any morphology that renders measurement of QT interval imprecise (eg, neuromuscular artifact that cannot be readily eliminated, indistinct QRS onset, low-amplitude T-wave, merged T and U-waves, prominent U-waves, arrhythmia) on the screening or baseline ECG.
- Participant is not willing to refrain from marijuana or cannabinol-containing products for 7 days before the first dose of study drug and throughout the study;
- Participant has consumed caffeine- or xanthine containing products within 24 hours prior to first dose of study drug or throughout the study;
- Participant has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade) within 28 days before the first dose of study drug or throughout the study;
- Participant has consumed fruit juices 72 hours prior to first dosing or during the study (with exception to the juices in relation to the fruits specified above);
- Participant has consumed vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussel sprouts, and mustard), or charbroiled meats for 7 days prior to first dose of study drug or throughout the study;
- Participant is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, vaporizers, or inhalers) within 6 months before the first dose of study drug;
- Participant has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake >21 units per week for male participants and >14 units of alcohol per week for female participants) (1 unit is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits) or consumed alcohol 72 hours before the first dose of study drug or throughout the follow-up telephone call;
- Participant is involved in strenuous activity or contact sports within 24 hours before the first dose of study drug or throughout the study;
- Participant has a history of relevant drug and/or food allergies (ie, allergy to mitapivat or excipients [microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate, and mannitol]);
- 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;
- In the opinion of the investigator, the participant is not suitable for entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Four-Period, Crossover Food-Effect Study With Mitapivat Sulfate In Healthy Subjects
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.
- Conditions
- Healthy Volunteers
- Being tested
- Placebo for Treatment A, Mitapivat 100 mg, Placebo for Treatment B, Mitapivat 300 mg, Placebo for Treatment C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo for Treatment ADrug
6 tablets matched to mitapivat tablet
Mitapivat 100 mgDrug
Also called AG-348
Two 50-mg tablets
Placebo for Treatment BDrug
4 tablets matched to mitapivat tablet
Mitapivat 300 mgDrug
Also called AG-348
Six 50-mg tablets
Placebo for Treatment CDrug
4 tablets matched to mitapivat tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Placebo comparator | Participants will receive a single oral dose of mitapivat-matching placebo under fasted conditions on Day 1 of each of 4 periods. Receives: Drug: Placebo for Treatment A |
| Treatment B | Experimental | 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. Receives: Drug: Mitapivat 100 mg; Drug: Placebo for Treatment B |
| Treatment C | Experimental | 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. Receives: Drug: Mitapivat 100 mg; Drug: Placebo for Treatment C |
| Treatment D | Experimental | Participants will receive a single oral dose of mitapivat 300 mg under fasted conditions on Day 1 of each of 4 periods. Receives: Drug: Mitapivat 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Predose and at various timepoints through 120 hours postdose within each 7-day period
AUC From Time 0 Extrapolated to Infinity (AUC0-Inf) for Mitapivat Under Fasted and High-Fat Meal Conditions
Measured: Predose and at various timepoints through 120 hours postdose within each 7-day period
Maximum Observed Plasma Concentration (Cmax) for Mitapivat Under Fasted and High-Fat Meal Conditions
Measured: Predose and at various timepoints through 120 hours postdose within each 7-day period
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Mitapivat Under Fasted and High-Fat Meal Conditions
Measured: Predose and at various timepoints through 120 hours postdose within each 7-day period
Apparent Terminal Elimination Half-Life (T1/2) for Mitapivat Under Fasted and High-Fat Meal Conditions
Measured: Predose and at various timepoints through 120 hours postdose within each 7-day period
Apparent Oral Clearance (CL/F) for Mitapivat Under Fasted and High-Fat Meal Conditions
Measured: Predose and at various timepoints through 120 hours postdose within each 7-day period
Apparent Terminal Elimination Rate Constant (Λz) for Mitapivat Under Fasted and High-Fat Meal Conditions
Measured: Predose and at various timepoints through 120 hours postdose within each 7-day period
Apparent Volume of Distribution (Vd/F) for Mitapivat Under Fasted and High-Fat Meal Conditions
Measured: Predose and at various timepoints through 120 hours postdose within each 7-day period
Relative Bioavailability (Frel; AUC0-Inf [fed]/AUC0-Inf [fasted]) for Fed Treatment Following Administration of Mitapivat 100-mg Dose
Measured: Predose and at various timepoints through 120 hours postdose within each 7-day period
Secondary outcomes (5)
Percentage of Participants With Adverse Events (AEs)
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.
Measured: Up to approximately 8 weeks
Percentage of Participants with Abnormalities in Clinical Laboratory Findings
Clinical laboratory tests will include hematology, serum chemistry, and urinalysis.
Measured: Up to approximately 8 weeks
Percentage of Participants With Abnormalities in Vital Sign Measurements
Vital sign measurements will include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.
Measured: Up to approximately 8 weeks
Percentage of Participants With Abnormalities in 12-lead Electrocardiogram (ECG) Results
Measured: Up to approximately 8 weeks
Percentage of Participants With Abnormalities in Physical Examination Findings
Measured: Up to approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start17 Jun 2020
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Agios Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Affairs, Study chair, Agios Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472832
- Sponsor's protocol ID
- AG348-C-014
- Status last verified
- Feb 2021
- First submitted
- 13 Jul 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Four-Period, Crossover Food-Effect Study With Mitapivat Sulfate In Healthy Subjects
- ClinicalTrials.gov ID
- NCT04472832
- Acronym / sponsor ID
- AG348-C-014
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Placebo comparator | Drug: Placebo for Treatment AParticipants will receive a single oral dose of mitapivat-matching placebo under fasted conditions on Day 1 of each of 4 periods. |
| Treatment B | Experimental | Drug: Mitapivat 100 mg, Drug: Placebo for Treatment BParticipants will receive a single oral dose of mitapivat 100 milligrams (mg) and placebo under fasted conditions on Day 1 of each of 4 periods. |
| Treatment C | Experimental | Drug: Mitapivat 100 mg, Drug: Placebo for Treatment CParticipants 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. |
| Treatment D | Experimental | Drug: Mitapivat 300 mgParticipants will receive a single oral dose of mitapivat 300 mg under fasted conditions on Day 1 of each of 4 periods. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Participant is male or female 18 to 55 years of age, inclusive;
- If female, is not currently pregnant or breastfeeding OR is of non-childbearing potential, defined as either:
- If male, agrees to abstain from sexual intercourse with a female partner OR agrees to use a highly effective form of contraception, beginning at the time of screening and continuing throughout the study and for 90 days after dosing, AND to refrain from donating sperm for the duration of the study and for 90 days after dosing;
- Participant has a body mass index 18 to 32 kilograms per square meter (kg/m^2), inclusive, at screening;
- Participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening;
Key exclusion criteria (33 listed)
- Participant has any medical or surgical condition that, in the opinion of the investigator, could affect study drug absorption, distribution, metabolism, or excretion;
- Participant has undergone any major surgical procedure within the 3 months prior to screening;
- Participant has a history of any primary malignancy (including any melanoma or suspicious undiagnosed skin lesions), with the exception of in situ basal cell or squamous cell carcinomas of the skin, cervical carcinoma in situ, or other malignancies that have been curatively treated and for which the participant has displayed no evidence of disease within the 5 years prior to screening;
- Participant has glucose-6-phosphate-dehydrogenase deficiency;
- Participant has a known history or presence of liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo for Treatment A6 tablets matched to mitapivat tablet | Drug | Treatment A |
| Mitapivat 100 mgAlso: AG-348Two 50-mg tablets | Drug | Treatment B, Treatment C |
| Placebo for Treatment B4 tablets matched to mitapivat tablet | Drug | Treatment B |
| Mitapivat 300 mgAlso: AG-348Six 50-mg tablets | Drug | Treatment D |
| Placebo for Treatment C4 tablets matched to mitapivat tablet | Drug | Treatment C |
Primary outcome
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
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
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
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
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
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
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
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
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
5 secondary outcomes
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 8 weeks
Percentage of Participants with Abnormalities in Clinical Laboratory Findings
Time frame: Up to approximately 8 weeks
Percentage of Participants With Abnormalities in Vital Sign Measurements
Time frame: Up to approximately 8 weeks
Percentage of Participants With Abnormalities in 12-lead Electrocardiogram (ECG) Results
Time frame: Up to approximately 8 weeks
Percentage of Participants With Abnormalities in Physical Examination Findings
Time frame: Up to approximately 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Affairs study chair
Agios Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mitapivat 100 mg and Mitapivat 300 mg 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 14 inclusion and 33 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 18 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2021.