A PK Study to Assess the Drug-drug Interaction of a BCRP Inhibitor on Adagrasib

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT05924152
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Adults

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

A Phase 1, Open-label, One-sequence Crossover Study to Investigate the Effect of a Breast Cancer Resistance Protein Inhibitor on the Single-dose Pharmacokinetics of Adagrasib in Healthy Adult Subjects

Key Dates

Start date
Jun 29, 2023
Status verified
Mar 2024
Primary completion
Aug 9, 2023
Completion
Aug 17, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Treatment A
    Treatment A: A single oral dose of adagrasib 400 mg (2 × 200-mg tablets) on Day 1;
  • Active Comparator: Treatment B
    Treatment B: A single oral dose of eltrombopag 75 mg (1 × 75-mg tablet) plus adagrasib 400 mg (2 × 200-mg tablets) on Day 8.

Primary Outcome Measure

Pharmacokinetics - AUC (adagrasib) [ Time Frame: Days 1 and 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fortrea Clinical Research Unit Daytona Beach (Labcorp Clinical Research Unit Daytona Beach)Daytona BeachFlorida32117-

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By research site
Fortrea Clinical Research Unit Daytona Beach (Labcorp Clinical Research Unit Daytona Beach)· Daytona Beach, FL

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