18 Participants Needed

Itraconazole and Divarasib Interaction Study

Recruiting at -1 trial locations
RS
Overseen ByReference Study ID Number: GP45714 https://forpatients.roche.com/
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Genentech, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

CT

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
2Treatment groups
Experimental Treatment
Group I: Treatment BExperimental Treatment2 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 AExperimental Treatment1 Intervention
Participants will receive a single oral dose of Divarasib on Day 1.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

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