A Study to Compare the Pharmacokinetics and Safety of Mitapivat 100 mg Tablet Formulation With Mitapivat 2 × 50 mg Tablet Formulation in Healthy Adult Participants

Part of paid clinical trials in Austin, Texas.

Sponsor
Agios Pharmaceuticals, Inc.
Study ID
NCT04696393
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The primary purpose of this study is to characterize and compare the pharmacokinetic profiles of mitapivat following a single dose administration of 100 mg mitapivat in two tablet formulations (50 mg and 100 mg tablet strengths) in healthy adult participants.

Key Dates

Start date
Jan 6, 2021
Status verified
Apr 2021
Primary completion
Mar 19, 2021
Completion
Mar 19, 2021

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Sequence 1: AB
    Participants will receive Treatment A (mitapivat 100 milligram \[mg\] tablet formulation, orally, under fasted conditions once on Day 1 of Period 1), followed by Treatment B (mitapivat 2 x 50 mg tablet formulation, orally, under fasted conditions once on Day 1 of Period 2). Each treatment period will be separated by a washout period of at least 7 days.
  • Experimental: Treatment Sequence 1: BA
    Participants will receive Treatment B (mitapivat 2 x 50 mg tablet formulation, orally, under fasted conditions once on Day 1 of Period 1), followed by Treatment A (mitapivat 100 mg tablet formulation, orally, under fasted conditions once on Day 1 of Period 2). Each treatment period will be separated by a washout period of at least 7 days.

Primary Outcome Measure

Area Under the Plasma Concentration Versus Time Curve (AUC) of Mitapivat From Time 0 to the Last Quantifiable Concentration (AUC0-t) [ Time Frame: Pre-dose and multiple time points post-dose (up to 120 hours) ]

Locations (1)

FacilityCityStateZIPSite coordinators
PPD Development, LPAustinTexas78744-

Find similar trials in Austin, TX

By research site
PPD Development, LP· Austin, TX

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