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

NCT ID: NCT07051993

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-27
• Study Completion Date: 2025-07-12

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1: ZN-A-1041

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

Group Type: EXPERIMENTAL

ZN-A-1041

Intervention Type: DRUG

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

Interventions

ZN-A-1041

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Fortrea Leeds CRU

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

GP45607

Identifier Type: -

Identifier Source: org_study_id