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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Relative Bioavailability Studies With Mitapivat: Formulation and Food Effect Assessments in Healthy Subjects.

Varsha Iyer1,2, Karen Sullivan1,3, Yan Yan1

  • 1Agios Pharmaceuticals, Inc., Cambridge, MA, USA.

Clinical Pharmacology in Drug Development
|October 25, 2024
PubMed
Summary

Mitapivat, a pyruvate kinase (PK) activator, shows consistent total exposure in healthy adults regardless of food intake. This supports flexible dosing for patients with PK deficiency anemia.

Keywords:
bioavailabilitybiopharmaceuticsclinical pharmacologyclinical trialsdrug‐food interactionsmitapivatpediatric formulationspharmacokineticsrare diseases

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Area of Science:

  • Pharmacology
  • Hematology
  • Drug Development

Background:

  • Pyruvate kinase (PK) deficiency is a rare genetic hemolytic anemia.
  • Mitapivat is an oral, allosteric activator of PK, investigated for treating PK deficiency.

Purpose of the Study:

  • To characterize mitapivat pharmacokinetics across different formulations.
  • To evaluate the effect of food on mitapivat bioavailability and exposure in healthy adults.

Main Methods:

  • Phase 1 clinical trials involving healthy adults.
  • Assessment of pharmacokinetic parameters including peak exposure, total exposure, and time to maximum concentration.
  • Comparison of mitapivat bioavailability across capsule, tablet, and pediatric granule formulations.
  • Analysis of food effects (high-fat meal, soft foods) on mitapivat absorption.

Main Results:

  • Plasma total exposure of mitapivat was similar in fasted and fed states across all tested formulations.
  • Food intake delayed the rate of mitapivat absorption (reduced Cmax and delayed Tmax) but did not impact overall exposure.
  • These pharmacokinetic findings were deemed not clinically relevant.

Conclusions:

  • Mitapivat can be taken with or without food, simplifying administration for patients.
  • These results support further clinical development of mitapivat for hemolytic anemias.
  • Findings inform dosing and administration recommendations for healthcare professionals.