A Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-… (NCT07329972) | Clinical Trial Compass
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 range18 Years – 75 Years
SexALL
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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…
What they're measuring
1
Maximum Observed Concentration (Cmax)
Timeframe: Days 1 to 8, 11 to 14, and 17 to 20
2
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
3
AUC Extrapolated to Infinity (AUC0-∞)
Timeframe: Days 1 to 8, 11 to 14, and 17 to 20
4
Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax, AUC0-t, and AUC0-∞