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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

Not Applicable
Recruiting
Conditions
Healthy Participants
Interventions
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
GroupInterventionDescription
Part 1: ZN-A-1041ZN-A-1041Participants will be administered a single dose of ZN-A-1041 orally.
Part 2: Rabeprazole and ZN-A-1041ZN-A-1041Participants 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-1041RabeprazoleParticipants will be administed rabeprazole, orally, twice daily (BID). Participants will be administered a single dose of ZN-A-1041 orally.
Primary Outcome Measures
NameTimeMethod
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 CmaxDays 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2)
Geometric Mean Ratio and Associated 90% CI of AUC0-tDays 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2)
Geometric Mean Ratio and Associated 90% CI of AUC0-infDays 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2)
Secondary Outcome Measures
NameTimeMethod
Time to Maximum Observed Concentration (tmax)Days 1-12 (Part 1), Days 1-8, 11-14, 17-20 (Part 2)
Apparent Terminal Elimination Rate ConstantDays 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)

Trial Locations

Locations (1)

Fortrea Leeds CRU

🇬🇧

Leeds, United Kingdom

Fortrea Leeds CRU
🇬🇧Leeds, United Kingdom

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