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

Genentech, Inc.19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

DigoxinDRUG

Digoxin will be administered together with Rosuvastatin as a drug cocktail as specified for the respective period

DivarasibDRUG

Divarasib will be administered in combination with Digoxin and Rosuvastatin as specified for the respective period

RosuvastatinDRUG

Rosuvastatin will be administered together with Digoxin as a drug cocktail as specified for the respective period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females of non-childbearing potential * Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive Exclusion Criteria: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator * Poor peripheral venous access

Locations (1)

Daytona Beach Clinical Rsch Unit

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax) of Digoxin and Rosuvastatin

Time frame: Day 1 of Period 1 and Day 5 of Period 2

Area Under the Plasma Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Digoxin and Rosuvastatin

Time frame: Day 1 of Period 1 and Day 5 of Period 2

Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Digoxin and Rosuvastatin

Time frame: Day 1 of Period 1 and Day 5 of Period 2

Time to Cmax (Tmax) of Digoxin and Rosuvastatin

Time frame: Day 1 of Period 1 and Day 5 of Period 2

Secondary Outcomes

Percentage of Participants with Adverse Events (AEs)

Time frame: From Day 1 until end of study participation (approximately 2 months)

Data from ClinicalTrials.gov

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