A Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 in Healthy Participants
A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 Tablet(s) in Healthy Participants
1 other identifier
interventional
48
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Nov 2025
Typical duration for phase_1 healthy-volunteers
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2025
CompletedStudy Start
First participant enrolled
November 21, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 12, 2026
April 2, 2026
April 1, 2026
9 months
November 20, 2025
April 1, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Maximum Observed Concentration (Cmax)
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)
Days 1 to 8, 11 to 14, and 17 to 20
AUC Extrapolated to Infinity (AUC0-∞)
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-∞
Days 1 to 8, 11 to 14, and 17 to 20
Secondary Outcomes (18)
ZN-A-1041 PK Parameters Time to Maximum Observed Concentration (Tmax) for All Treatments
Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Terminal Elimination Rate Constant (λz) for All Treatments
Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Terminal Elimination Half-life (t1/2) for All Treatments
Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Systemic Clearance (CL/F) for All Treatments
Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for All Treatments
Days 1 to 8, 11 to 14, and 17 to 20
- +13 more secondary outcomes
Study Arms (8)
Sequence 1
EXPERIMENTALSequence 2
EXPERIMENTALSequence 3
EXPERIMENTALSequence 4
EXPERIMENTALSequence 5
EXPERIMENTALSequence 6
EXPERIMENTALSequence 7
EXPERIMENTALSequence 8
EXPERIMENTALInterventions
Participants will receive a single dose of ZN-A-1041 Formulation 1 on each specified treatment.
Participants will receive a single dose of ZN-A-1041 Formulation 2 on each specified treatment.
Participants will receive an oral administration of rabeprazole twice daily (BID) on days 9, 10, 15, and 16 and a single dose on Days 11 and 17.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder, as determined by the investigator
- History or concurrent clinically significant hemorrhagic, bleeding abnormalities, as determined by the investigator
- Personal or family history of congenital long QT syndrome
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
- History of GI surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that uncomplicated appendectomy and hernia repair will be allowed
- History of myocardial infarction
- History of febrile illness within 10 days prior to the first dose of study drug, or participants with evidence of active systemic infection, as determined by the investigator
- History of acute GI symptoms (e.g., nausea, vomiting, diarrhea, heartburn) as determined by the investigator (or designee) at Screening or Check-in
- History of ophthalmological disease or clinically significant abnormality in the ophthalmic examination as determined by the investigator, optometrist, or ophthalmologist
- Have significantly impaired hepatic function (at Screening or Check-in)
- Female who is pregnant or breastfeeding or intending to become pregnant during the study or within 90 days following the final ZN-A-1041 administration
- Have a corrected QT (QTc) interval corrected through use of Fredericia's formula \>450 msec for males or \>470 for females, PR interval \>210 msec, QRS complex \>120 msec, or heart rate \<50 bpm (at Screening or Check-in)
- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically significant, such as symptomatic bradyarrhythmias, bradycardia, or heart block as determined from 12-lead ECG (at Screening, Check-in, or Day 1 predose). Abnormal results can be confirmed by one repeat 12-lead ECG
- History of alcoholism or drug addiction within 1 year prior to Check-in, use of drugs of abuse (including opioids) within 4 weeks of Screening, and/or positive alcohol breath test and/or urinary drug screen at Screening or Check-in
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 90 days, whichever is longer, prior to Check-in
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (2)
Daytona Beach Clinical Rsch Unit
Daytona Beach, Florida, 32117, United States
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4989, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: GP46367 https://forpatients.roche.com/
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2025
First Posted
January 9, 2026
Study Start
November 21, 2025
Primary Completion (Estimated)
August 8, 2026
Study Completion (Estimated)
August 12, 2026
Last Updated
April 2, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share