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Last Updated: May 24, 2024

CLINICAL TRIALS PROFILE FOR MITAPIVAT SULFATE


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All Clinical Trials for Mitapivat Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03991312 ↗ Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Participants Completed Agios Pharmaceuticals, Inc. Phase 1 2019-06-20 Part 1 of this study will determine the effect of multiple-dose itraconazole, a strong cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) inhibitor, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants. Part 2 of this study will determine the effect of multiple-dose rifampin, a strong CYP3A4 and P-gp inducer, on the single-dose pharmacokinetic(s) (PK) of mitapivat sulfate in healthy adult participants.
NCT04000165 ↗ Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Multiple Oral Doses of AG-348 in Subjects With Stable Sickle Cell Disease Completed National Heart, Lung, and Blood Institute (NHLBI) Early Phase 1 2019-07-11 Background: Sickle Cell Disease (SCD) is an inherited blood disorder. People with SCD have abnormal hemoglobin in their red blood cells. Researchers are investigating the safety and efficacy of an investigational medicine called AG-348 (mitapivat sulfate) to determine if it will help people with SCD. Objective: To test the tolerability and safety of AG-348 in people with SCD. Eligibility: People ages 18 and older with SCD. Design: Participants will have 8 visits over approximately 14 weeks. At the first visit participants will be screened with a medical history; a physical exam; and blood, urine, and heart tests. At the following 5 visits participants will stay at the clinic for 1 night each. Participants will take study drug in increasing doses upto visit 6, after which the drug will be tapered off. All visits will include physical exam, blood, and urine tests. The last visit will occur 4 weeks after stopping the drug and also includes a heart test. Participants will provide DNA from the blood samples they provide. The DNA will be tested for an inherited gene that can cause differences in response to the study drug. Researchers may also test other genes to see if they can find any genes that interact with SCD.
NCT04000165 ↗ Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Multiple Oral Doses of AG-348 in Subjects With Stable Sickle Cell Disease Completed National Institutes of Health Clinical Center (CC) Early Phase 1 2019-07-11 Background: Sickle Cell Disease (SCD) is an inherited blood disorder. People with SCD have abnormal hemoglobin in their red blood cells. Researchers are investigating the safety and efficacy of an investigational medicine called AG-348 (mitapivat sulfate) to determine if it will help people with SCD. Objective: To test the tolerability and safety of AG-348 in people with SCD. Eligibility: People ages 18 and older with SCD. Design: Participants will have 8 visits over approximately 14 weeks. At the first visit participants will be screened with a medical history; a physical exam; and blood, urine, and heart tests. At the following 5 visits participants will stay at the clinic for 1 night each. Participants will take study drug in increasing doses upto visit 6, after which the drug will be tapered off. All visits will include physical exam, blood, and urine tests. The last visit will occur 4 weeks after stopping the drug and also includes a heart test. Participants will provide DNA from the blood samples they provide. The DNA will be tested for an inherited gene that can cause differences in response to the study drug. Researchers may also test other genes to see if they can find any genes that interact with SCD.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Mitapivat Sulfate

Condition Name

Condition Name for Mitapivat Sulfate
Intervention Trials
Healthy Volunteers 4
Sickle Cell Disease 2
Moderate Hepatic Impairment 1
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Condition MeSH

Condition MeSH for Mitapivat Sulfate
Intervention Trials
Anemia, Hemolytic 3
Thalassemia 2
beta-Thalassemia 2
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Clinical Trial Locations for Mitapivat Sulfate

Trials by Country

Trials by Country for Mitapivat Sulfate
Location Trials
United States 7
Canada 4
Japan 1
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Trials by US State

Trials by US State for Mitapivat Sulfate
Location Trials
Texas 3
Massachusetts 2
Maryland 1
Arizona 1
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Clinical Trial Progress for Mitapivat Sulfate

Clinical Trial Phase

Clinical Trial Phase for Mitapivat Sulfate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Mitapivat Sulfate
Clinical Trial Phase Trials
Not yet recruiting 5
Completed 5
Recruiting 2
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Clinical Trial Sponsors for Mitapivat Sulfate

Sponsor Name

Sponsor Name for Mitapivat Sulfate
Sponsor Trials
Agios Pharmaceuticals, Inc. 11
National Heart, Lung, and Blood Institute (NHLBI) 2
National Institutes of Health Clinical Center (CC) 1
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Sponsor Type

Sponsor Type for Mitapivat Sulfate
Sponsor Trials
Industry 11
NIH 3
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