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

Completed

• Conditions: Healthy Participants
• Interventions: Drug: ZN-A-1041

• 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. No participants were enrolled in Part 2 of the study as it has been cancelled.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Study Start: 2025-06-27
• Study First Posted: 2025-07-04
• Primary Completion: 2025-07-12
• Study Completion: 2025-07-12
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-14
• Last Update Posted: 2025-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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: SINGLE_GROUP

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.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Concentration (Cmax)	Days 1-12 (Part 1)
Area Under the Concentration-Time curve from Hour 0 to the Last Measurable Concentration (AUC0-t)	Days 1-12 (Part 1)
AUC Extrapolated to Infinity (AUC0-inf)	Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax	Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% CI of AUC0-t	Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% CI of AUC0-inf	Days 1-12 (Part 1)

Secondary Outcome Measures

Name	Time	Method
Time to Maximum Observed Concentration (tmax)	Days 1-12 (Part 1)
Apparent Terminal Elimination Rate Constant	Days 1-12 (Part 1)
Apparent Terminal Elimination Half-Life (t1/2)	Days 1-12 (Part 1)
Apparent Systemic Clearance (CL/F)	Days 1-12 (Part 1)
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)	Days 1-12 (Part 1)
Percentage of Participants With Adverse Events (AEs)	Up to approximately 16 days
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)

Trial Locations

Locations (1)

Fortrea Leeds CRU; 🇬🇧 Leeds, United Kingdom