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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Digoxin; Drug: Rosuvastatin; Drug: Divarasib

• Registration Number: NCT06677957
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Study Start: 2024-11-06
• Study First Posted: 2024-11-07
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of Digoxin and Rosuvastatin	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	Day 1 of Period 1 and Day 5 of Period 2
Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Digoxin and Rosuvastatin	Day 1 of Period 1 and Day 5 of Period 2
Time to Cmax (Tmax) of Digoxin and Rosuvastatin	Day 1 of Period 1 and Day 5 of Period 2

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Adverse Events (AEs)	From Day 1 until end of study participation (approximately 2 months)

Trial Locations

Locations (1)

Daytona Beach Clinical Rsch Unit; 🇺🇸 Daytona Beach, Florida, United States