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A Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 in Healthy Participants
Healthy Volunteers
- For Medical Professional
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Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 1
Trial Identifier
NCT07329972, GP46367
Condition
Healthy Volunteers
Official Title
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
Study 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 Criteria
All
≥18 Years & ≤ 75 Years
Accepts Healthy Volunteers
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)
- Negative hepatitis panel (hepatitis B surface antigen, hepatitis B core antibody, hepatitis B surface antibody [unless consistent with vaccination or immunity due to natural infection], and hepatitis C virus antibody) and negative HIV antibody screens
- For women of childbearing potential: agreement to remain abstinent or use contraception
- For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm
- Negative screening test for latent Mycobacterium tuberculosis infection
- Able to swallow and retain multiple tablets without chewing or crushing
- 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, gastrointestinal (GI), neurological, or psychiatric disorder, as determined by the investigator
- History or concurrent clinically significant hemorrhagic, bleeding abnormalities, as determined by the investigator
- Personal or family history of congenital long QT syndrome
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
- History of GI surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that uncomplicated appendectomy and hernia repair will be allowed
- History of myocardial infarction
- History of febrile illness within 10 days prior to the first dose of study drug, or participants with evidence of active systemic infection, as determined by the investigator
- History of acute GI symptoms (e.g., nausea, vomiting, diarrhea, heartburn) as determined by the investigator (or designee) at Screening or Check-in
- History of ophthalmological disease or clinically significant abnormality in the ophthalmic examination as determined by the investigator, optometrist, or ophthalmologist
- Risk for suicidal behavior at Screening as determined by the investigator's clinical assessment and an answer "Yes" to item 4 or 5 within 2 years of Screening, or to suicidal behavior items on the Baseline/Screening version C-SSRS or suicide attempt within 2 years of screening. Non-suicidal self-injurious behavior is not exclusionary.
- Have significantly impaired hepatic function (at Screening or Check-in)
- 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 corrected QT (QTc) interval corrected through use of Fredericia's formula >450 msec for males or >470 for females, PR interval >210 msec, QRS complex >120 msec, or heart rate <50 bpm (at Screening or Check-in)
- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically significant, such as symptomatic bradyarrhythmias, bradycardia, or heart block as determined from 12-lead ECG (at Screening, Check-in, or Day 1 predose). Abnormal results can be confirmed by one repeat 12-lead ECG
- History of alcoholism or drug addiction within 1 year prior to Check-in, use of drugs of abuse (including opioids) within 4 weeks of Screening, and/or positive alcohol breath test and/or urinary drug screen at Screening or Check-in
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 90 days, whichever is longer, prior to Check-in
- Treatment with intravenous (IV) antibiotics within 8 weeks prior to Screening and/or treatment with oral antibiotics within 4 weeks prior to Screening
- Use of any drugs known to be moderate or strong inhibitors or inducers of CYP3A or CYP2C8 within 30 days prior to Check-in
- Use of any other prescription medications/products or vaccines (including seasonal flu, H1N1, and coronavirus 2019 [COVID-19] vaccines) other than oral, implantable, transdermal, and injectable contraceptives or medications administered during the ophthalmic examination within 14 days prior to Check-in, unless deemed acceptable by the investigator
- Use of therapeutic anticoagulation or thrombolytic anticoagulants within 14 days prior to Check-in
- Use of any over-the-counter, non-prescription medications (including vitamins; minerals; and phytotherapeutic-, herbal-, and plant-derived preparations) within 7 days prior to Check-in, unless deemed acceptable by the investigator
- Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 3 months prior to Check-in or a positive cotinine test
- Use of poppy seed-, grapefruit-, star fruit-, pomegranate-, pawpaw-, or Seville orange-containing foods or beverages within 7 days prior to Check-in
- Use of alcohol- or caffeine-containing foods or beverages within 48 hours prior to Check-in, unless deemed acceptable by the investigator
- Participant is not willing to minimize or avoid exposure to natural or artificial sunlight (tanning beds or ultraviolet (UV) A/B treatment) following administration of study drug through 5 days following the final ZN-A-1041 administration
- Participant is not willing to refrain from strenuous exercise from 7 days prior to Check-in and during the period of confinement at the study site (e.g., will not begin a new exercise program or participate in any unusually strenuous physical exertion)
- Poor peripheral venous access as determined by the investigator
- History of malignancy within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix or basal cell skin cancer)
- Donation of blood within 3 months prior to Screening through study completion, donation of plasma within 2 weeks prior to Screening through study completion, or donation of platelets within 6 weeks prior to Screening through study completion
- Receipt of blood products within 2 months prior to Screening and during the entire study duration
- Participants who, in the opinion of the investigator (or designee), should not participate in this clinical study
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
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