A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 Tablet(s) in Healthy Participants

Genentech, Inc.

Summary

This study is a phase 1, open-label, randomized, four-period crossover study to evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation in healthy male and female participants.

Eligibility

Age range: 18–75 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Body mass index (BMI) within the range of 18 to 32 kg/m2, inclusive * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs, as determined by the investigator, at Screening and Check-in, as applicable * Clinical laboratory evaluations (including chemistry panel, CBC, and UA with complete microscopic analysis) within the normal reference ranges for the certified test laboratory at Screening and Check-in * Negative test for selected drugs of abuse at Screening and Check-in (includes alcohol…

Interventions

Drug
ZN-A-1041 Formulation 1
Participants will receive a single dose of ZN-A-1041 Formulation 1 on each specified treatment.
Drug
ZN-A-1041 Formulation 2
Participants will receive a single dose of ZN-A-1041 Formulation 2 on each specified treatment.
Drug
Rabeprazole
Participants will receive an oral administration of rabeprazole twice daily (BID) on days 9, 10, 15, and 16 and a single dose on Days 11 and 17.

Locations (2)

Daytona Beach Clinical Rsch Unit
Daytona Beach, Florida
Fortrea Clinical Research Unit - Dallas
Dallas, Texas

A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 Tablet(s) in Healthy Participants

Summary

Eligibility

Interventions

Locations (2)

Compensation

Run this study?

Details

Conditions