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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Agios Pharmaceuticals, Inc.
Study ID
NCT03991312
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • itraconazole — DRUG
    Participants will receive an oral solution as described in the arm description.
  • rifampin — DRUG
    Participants will receive oral capsule(s) as described in the arm description.
  • mitapivat sulfate — DRUG
    Participants will receive an oral tablet as described in the arm description.

Study Details

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.

Key Dates

Start date
Jun 20, 2019
Status verified
Oct 2019
Primary completion
Aug 14, 2019
Completion
Sep 10, 2019

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    Period 1: Day 1, participants will receive 20 milligrams (mg) of mitapivat sulfate. Period 2: Day 1 to Day 9, participants will receive 200 mg of itraconazole, once daily and 20 mg of mitapivat sulfate on Day 5.
  • Experimental: Part 2
    Period 1: Day 1, participants will receive 50 milligrams (mg) of mitapivat sulfate. Period 2: Day 1 to Day 12, participants will receive 600 mg of rifampin, once daily and 50 mg of mitapivat sulfate on Day 8.

Primary Outcome Measure

Area Under the Concentration-Time Curve, from Time 0 to the Last Measurable Concentration (AUC0-t) of Mitapivat Sulfate with and without Itraconazole [ Time Frame: Predose and at various timepoints through 120 hours postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, IncTempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion, Inc· Tempe, AZ

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