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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
Healthy Volunteers
Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 1
Study Identifier
NCT07051993, GP45607
Condition
Healthy Participants
Official Title
A Phase 1, Open-Label, Randomized, Crossover, Two-Part Study to Evaluate the Relative Bioavailability of Two ZN-A-1041 Tablet Formulations Compared to Capsule Formulation and the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 Tablet(s) in Healthy Subjects
Study 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.
Eligibility Criteria
All
≥18 Years & ≤ 75 Years
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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com