Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants

Part of paid clinical trials in Dallas, Texas.

Sponsor
Agios Pharmaceuticals, Inc.
Study ID
NCT06648824
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Mitapivat — DRUG
    Oral tablets
  • Midazolam — DRUG
    Oral syrup

Study Details

The primary purpose of this study is to assess the effect of mitapivat on the single oral dose pharmacokinetics (PK) of midazolam in healthy participants.

Key Dates

Start date
Oct 17, 2024
Status verified
Jan 2025
Primary completion
Dec 3, 2024
Completion
Dec 3, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mitapivat and Midazolam
    Participants will receive single oral dose of 2 milligram (mg) midazolam on Day 1 followed by 100 mg mitapivat, orally, twice daily (BID) from Day 3 to 13. On Day 14, participants will receive single oral dose of 2 mg midazolam and 100 mg mitapivat orally, BID. Midazolam will be co-administered with morning mitapivat dose.

Primary Outcome Measure

Area Under the Plasma Concentration-Time Curve Extrapolated From Time Zero to Infinity (AUC0-infinity) of Midazolam [ Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 14 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fortrea Clinical Research Unit Inc.DallasTexas75247-

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Fortrea Clinical Research Unit Inc.· Dallas, TX

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