Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT06801418
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Adagrasib — DRUG
    Specified dose on specified days

Study Details

This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants.

Key Dates

Start date
Feb 4, 2025
Status verified
Jun 2025
Primary completion
Jun 19, 2025
Completion
Jun 19, 2025

Study Design

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

Arms

  • Experimental: Adagrasib sequence A
  • Experimental: Adagrasib sequence B

Primary Outcome Measure

Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] [ Time Frame: Up to Day 28 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Local Institution - 0003LenexaKansas66219-9746-
Local Institution - 0002San AntonioTexas78209-1028-
Local Institution - 0001Salt Lake CityUtah84124-1365-

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By research site
Local Institution - 0003· Lenexa, KSLocal Institution - 0002· San Antonio, TXLocal Institution - 0001· Salt Lake City, UT

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