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

NCT07051993 | Completed Phase 1

• 1 other identifier: GP45607
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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)

Study Arms (1)

Part 1: ZN-A-1041

EXPERIMENTAL

Participants will be administered a single dose of ZN-A-1041 orally.

Drug: ZN-A-1041

Interventions

ZN-A-1041 DRUG

Participants will be administered either a ZN-A-1041 capsule or a tablet orally.

Part 1: ZN-A-1041

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Fortrea Leeds CRU

Leeds, LS11 9EH, United Kingdom

Location

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: June 27, 2025
• Primary Completion: July 12, 2025
• Study Completion: July 12, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)