A Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Resistance Protein in Healthy Participants

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Genentech, Inc.
Study ID
NCT06677957
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Digoxin — DRUG
    Digoxin will be administered together with Rosuvastatin as a drug cocktail as specified for the respective period
  • Divarasib — DRUG
    Divarasib will be administered in combination with Digoxin and Rosuvastatin as specified for the respective period
  • Rosuvastatin — DRUG
    Rosuvastatin will be administered together with Digoxin as a drug cocktail as specified for the respective period

Study Details

This is a Phase 1, open-label, two-period, one-sequence, crossover drug-drug interaction study to assess the P-gp and BCRP inhibition potential of divarasib using digoxin and rosuvastatin as probe substrates, respectively, in healthy participants.

Key Dates

Start date
Nov 6, 2024
Status verified
Jan 2025
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment A
    Participants will receive a single oral dose of Digoxin and Rosuvastatin drug cocktail.
  • Experimental: Treatment B
    Participants will receive a single dose of Digoxin and Rosuvastatin drug cocktail administered 2 hours after the Divarasib dose on Day 5.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Digoxin and Rosuvastatin [ Time Frame: Day 1 of Period 1 and Day 5 of Period 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Daytona Beach Clinical Rsch UnitDaytona BeachFlorida32117-

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By research site
Daytona Beach Clinical Rsch Unit· Daytona Beach, FL

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