A Study to Evaluate the Relative Bioavailability of Two Tablet Formulations Compared to Capsule Formulation and the Effect of Food and Proton Pump Inhibitor on ZN-A-1041 Tablet(s) in Healthy Participants
- Registration Number
- NCT07051993
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This is a Phase 1, open-label, randomized, two-part study to evaluate the relative bioavailability (rBA) of two tablet formulations compared to the capsule formulation of ZN-A-1041 (Part 1). Part 2 of the study will evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- Body mass index (BMI) within the range of 18 to 32 kg/m^2, inclusive
- Negative hepatitis panel and negative HIV antibody screens
- Negative screening test for latent Mycobacterium tuberculosis infection
- 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, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder
- Personal or family history of congenital long QT syndrome
- History of significant hypersensitivity, intolerance, or allergy to any drug
- History of acute GI symptoms
- History of ophthalmological disease or clinically significant abnormality in the ophthalmic examination
- Have significantly impaired hepatic function
- 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 QTc interval corrected through use of Fredericia's formula >450 millisecond (msec), PR interval >210 msec, QRS complex >120 msec, or heart rate <50 beats per minute (bpm)
- Use of any drugs known to be moderate or strong inhibitors or inducers of CYP3A or CYP2C8
- Poor peripheral venous access
- History of malignancy within 5 years prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: ZN-A-1041 ZN-A-1041 Participants will be administered a single dose of ZN-A-1041 orally. Part 2: Rabeprazole and ZN-A-1041 ZN-A-1041 Participants will be administed rabeprazole, orally, twice daily (BID). Participants will be administered a single dose of ZN-A-1041 orally. Part 2: Rabeprazole and ZN-A-1041 Rabeprazole Participants will be administed rabeprazole, orally, twice daily (BID). Participants will be administered a single dose of ZN-A-1041 orally.
- Primary Outcome Measures
Name Time Method Maximum Observed Concentration (Cmax) Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2) Area Under the Concentration-Time curve from Hour 0 to the Last Measurable Concentration (AUC0-t) Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2) AUC Extrapolated to Infinity (AUC0-inf) Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2) Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2) Geometric Mean Ratio and Associated 90% CI of AUC0-t Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2) Geometric Mean Ratio and Associated 90% CI of AUC0-inf Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2)
- Secondary Outcome Measures
Name Time Method Time to Maximum Observed Concentration (tmax) Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2) Apparent Terminal Elimination Rate Constant Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2) Apparent Terminal Elimination Half-Life (t1/2) Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2) Apparent Systemic Clearance (CL/F) Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2) Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2) Percentage of Participants With Adverse Events (AEs) Up to approximately 8.5 weeks Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline, days 1, 5, 9 and 12 (Part 1), Baseline, days 1, 5, 11, 17 and 20 (Part 2)
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which ZN-A-1041 interacts with its drug target in healthy participants?
How does the relative bioavailability of ZN-A-1041 tablet formulations compare to capsule in Phase 1 trials?
Which biomarkers could influence the pharmacokinetic response to ZN-A-1041 in the presence of proton pump inhibitors?
What adverse events are associated with ZN-A-1041 tablet formulations and how are they managed in clinical settings?
Are there other compounds or drug classes targeting similar pathways to ZN-A-1041 currently in development by Genentech or competitors?
Trial Locations
- Locations (1)
Fortrea Leeds CRU
🇬🇧Leeds, United Kingdom
Fortrea Leeds CRU🇬🇧Leeds, United Kingdom