CompletedPhase 1

A Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 in Healthy Participants

United States24 participantsStarted 2025-11-21

Plain-language summary

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 can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Body mass index (BMI) within the range of 18 to 32 kg/m2, inclusive * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs, as determined by the investigator, at Screening and Check-in, as applicable * Clinical laboratory evaluations (including chemistry panel, CBC, and UA with complete microscopic analysis) within the normal reference ranges for the certified test laboratory at Screening and Check-in * Negative test for selected drugs of abuse at Screening and Check-in (includes alcohol) * Negative hepatitis panel (hepatitis B surface antigen, hepatitis B core antibody, hepatitis B surface antibody \[unless consistent with vaccination or immunity due to natural infection\], and hepatitis C virus antibody) and negative HIV antibody screens * For women of childbearing potential: agreement to remain abstinent or use contraception * For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm * Negative screening test for latent Mycobacterium tuberculosis infection * Able to swallow and retain multiple tablets without chewing or crushing * Able to consume the high-fat meal within the protocol-specified time period and willing to consume 100% of the high-fat meal * Able to fast for 8 hours prior to dosing Exclusion Criteria: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Observed Concentration (Cmax)

Timeframe: Days 1 to 8, 11 to 14, and 17 to 20

Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t)

Timeframe: Days 1 to 8, 11 to 14, and 17 to 20

AUC Extrapolated to Infinity (AUC0-∞)

Timeframe: Days 1 to 8, 11 to 14, and 17 to 20

Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax, AUC0-t, and AUC0-∞

Timeframe: Days 1 to 8, 11 to 14, and 17 to 20

Trial details

NCT IDNCT07329972

SponsorGenentech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-14

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum Observed Concentration (Cmax)

Timeframe: Days 1 to 8, 11 to 14, and 17 to 20

Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t)

Timeframe: Days 1 to 8, 11 to 14, and 17 to 20

AUC Extrapolated to Infinity (AUC0-∞)

Timeframe: Days 1 to 8, 11 to 14, and 17 to 20

Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax, AUC0-t, and AUC0-∞

Timeframe: Days 1 to 8, 11 to 14, and 17 to 20