Itraconazole and Divarasib Interaction Study

Overseen By Reference Study ID Number: GP45714 https://forpatients.roche.com/

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Disqualifiers: Metabolic, Hepatic, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

18 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Trials

Principal Investigator

Genentech, Inc.

Eligibility Criteria

This trial is for healthy individuals who can participate in a study to understand how Itraconazole affects the body's handling of another drug, Divarasib. Specific eligibility criteria are not provided.

Inclusion Criteria

I cannot become pregnant or get someone pregnant.

My BMI is between 18.0 and 32.0.

Exclusion Criteria

History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator

I have difficulty with blood draws or IV insertions due to poor vein access.

I have no major health issues like heart, kidney, liver diseases, or severe allergies.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Period A

Participants receive a single oral dose of Divarasib on Day 1

1 day

1 visit (in-person)

Treatment Period B

Participants receive Itraconazole BID on Day 1 and QD from Day 2 to Day 13, with Divarasib on Day 5

13 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Divarasib
• Itraconazole

Trial Overview The study is testing how taking Itraconazole, an antifungal medication, influences the levels and effects of Divarasib, a potential new treatment being tested in healthy participants over two different periods.

Participant Groups

Group I: Treatment B Experimental Treatment 2 Interventions

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.

Group II: Treatment A Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD