NCT06677957

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

A Phase I, Open-Label, Two-Period, One-Sequence, Crossover Study in Healthy Subjects to Evaluate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein (Digoxin) and Breast Cancer Resistance Protein (Rosuvastatin)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

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

Timeline

• Start date: 2024-11-06
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-11-07
• Last updated: 2025-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study