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

NCT06690138 | Completed Phase 1 FDA Drug

• 1 other identifier: GP45714
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  Up to Week 12

Study Arms (2)

Treatment A

EXPERIMENTAL

Participants will receive a single oral dose of Divarasib on Day 1.

Drug: Divarasib

Treatment B

EXPERIMENTAL

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.

Drug: Divarasib; Drug: Itraconazole

Interventions

Divarasib DRUG

Divarasib will be administered as a single oral dose as specified for the respective period.

Treatment A; Treatment B

Itraconazole DRUG

Itraconazole will be administered BID on Day 1 and QD from Day 2 to 13 and as specified for the respective period.

Treatment B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females of non-childbearing potential
• Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Dallas Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: November 15, 2024
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)