ZN-A-1041 for Healthy Subjects

Overseen By Reference Study ID Number: GP46367 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must not be taking: Anticoagulants, CYP3A inhibitors

Disqualifiers: Metabolic disorders, Hepatic impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a phase 1, open-label, randomized, four-period crossover study to evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation in healthy male and female participants.

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI of 18-32. Participants must have normal medical exams, ECGs, vital signs, and lab tests. They can't use drugs or alcohol, must test negative for hepatitis and HIV, agree to contraception or abstinence, not donate sperm during the study, be able to swallow tablets whole and eat a high-fat meal as required.

Inclusion Criteria

I am in good health with no significant medical issues.

My recent blood and urine tests are within normal ranges.

I agree to use birth control or remain abstinent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a four-period crossover study to evaluate the effect of food and rabeprazole on the pharmacokinetics of ZN-A-1041

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rabeprazole

Trial Overview

The study is testing how food and Rabeprazole affect the body's handling of two formulations of ZN-A-1041 in healthy people. It's an open-label crossover study where participants will try each treatment in different periods to compare effects.

How Is the Trial Designed?

Group I: Sequence 8 Experimental Treatment 2 Interventions

Group II: Sequence 7 Experimental Treatment 2 Interventions

Group III: Sequence 6 Experimental Treatment 2 Interventions

Group IV: Sequence 5 Experimental Treatment 2 Interventions

Group V: Sequence 4 Experimental Treatment 2 Interventions

Group VI: Sequence 3 Experimental Treatment 2 Interventions

Group VII: Sequence 2 Experimental Treatment 2 Interventions

Group VIII: Sequence 1 Experimental Treatment 2 Interventions

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