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

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: ZN-A-1041

Study type

Interventional

Funder types

Industry

Identifiers

NCT07051993

GP45607

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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