A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants

Part of paid clinical trials in Austin, Texas.

Sponsor
Agios Pharmaceuticals, Inc.
Study ID
NCT04472832
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo for Treatment A — DRUG
    6 tablets matched to mitapivat tablet
  • Mitapivat 100 mg — DRUG
    Two 50-mg tablets
  • Placebo for Treatment B — DRUG
    4 tablets matched to mitapivat tablet
  • Mitapivat 300 mg — DRUG
    Six 50-mg tablets
  • Placebo for Treatment C — DRUG
    4 tablets matched to mitapivat tablet

Study Details

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.

Key Dates

Start date
Jun 17, 2020
Status verified
Feb 2021
Primary completion
Nov 23, 2020
Completion
Nov 23, 2020

Study Design

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

Arms

  • Placebo Comparator: Treatment A
    Participants will receive a single oral dose of mitapivat-matching placebo under fasted conditions on Day 1 of each of 4 periods.
  • Experimental: Treatment B
    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.
  • Experimental: Treatment C
    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.
  • Experimental: Treatment D
    Participants will receive a single oral dose of mitapivat 300 mg under fasted conditions on Day 1 of each of 4 periods.

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
PPD Development, LPAustinTexas78744-

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By research site
PPD Development, LP· Austin, TX

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