A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID
NCT07118215
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • KarXT — DRUG
    Specified dose on specified days
  • Midazolam — DRUG
    Specified dose on specified days
  • Fexofenadine — DRUG
    Specified dose on specified days
  • Digoxin — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.

Key Dates

Start date
Sep 29, 2025
Status verified
Jun 2026
Primary completion
Jun 25, 2026
Completion
Jun 25, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
  • Experimental: Part 2
  • Experimental: Part 3
  • Experimental: Part 1a

Primary Outcome Measure

Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT [ Time Frame: Up to approximately day 24 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (1)

FacilityCityStateZIPSite coordinators
ICON - LenexaLenexaKansas66219-9746
Patrick Yao, Site 0001
913-410-2674

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ICON - Lenexa· Lenexa, KS

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