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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Divarasib; Drug: Itraconazole

• Registration Number: NCT06690138
• Lead Sponsor: Genentech, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study Start: 2024-11-15
• Study First Posted: 2024-11-15
• Primary Completion: 2025-02-11
• Study Completion: 2025-02-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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	Divarasib	Participants will receive a single oral dose of Divarasib on Day 1.
Treatment B	Divarasib	Participants will receive Itraconazole twice a day (BID) on Day 1 and once a day (QD) from Day 2 to Day 13. Participants will receive Divarasib in combination with Itraconazole on Day 5.
Treatment B	Itraconazole	Participants will receive Itraconazole twice a day (BID) on Day 1 and once a day (QD) from Day 2 to Day 13. Participants will receive Divarasib in combination with Itraconazole on Day 5.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of Divarasib	Day 1 of Period 1 and Day 5 of Period 2
Area Under the Concentration-time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Divarasib	Day 1 of Period 1 and Day 5 of Period 2
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib	Day 1 of Period 1 and Day 5 of Period 2

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	Up to Week 12

Trial Locations

Locations (1)

Dallas Clinical Research Unit; 🇺🇸 Dallas, Texas, United States