NCT06690138

A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants

A Phase 1, Open-Label, Single-Dose, Two-Period, Fixed Sequence, Crossover Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (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, fixed sequence drug-drug interaction study to evaluate the impact of multiple doses of Itraconazole on the pharmacokinetics (PK) and safety of Divarasib in healthy participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Divarasib	Divarasib will be administered as a single oral dose as specified for the respective period.
DRUG	Itraconazole	Itraconazole will be administered BID on Day 1 and QD from Day 2 to 13 and as specified for the respective period.

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-02-11
• Completion: 2025-02-11
• First posted: 2024-11-15
• Last updated: 2025-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study