Rifampin + Divarasib for Drug Interaction Study

Recruiting at 1 trial location

Overseen By Reference Study ID Number: GP45718 https://forpatients.roche.com/

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Disqualifiers: Metabolic, Hepatic, Renal, 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

What You Need to Know Before You Apply

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 rifampin on the pharmacokinetics (PK) and safety of divarasib in healthy participants.

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy men and women who can't have children. Participants must have a body mass index (BMI) between 18.0 to 32.0 kg/m2.

Inclusion Criteria

My BMI is between 18.0 and 32.0.

I cannot become pregnant or get someone pregnant.

Timeline for a Trial Participant

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 Rifampin once daily on Days 1 to 7 and Days 9 to 13, with Divarasib followed by Rifampin on Day 8

13 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Divarasib
• Rifampin

Trial Overview The study is testing how rifampin, an antibiotic, affects the levels and safety of divarasib, a new drug, in the bodies of healthy people.

How Is the Trial Designed?

Group I: Treatment B Experimental Treatment 2 Interventions

Participants will receive Rifampin once daily (QD) on Days 1 to 7 and Days 9 to 13. Participants will receive Divarasib followed by Rifampin on Day 8.

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