NCT07329972已完成1 期
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
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax, AUC0-t, and AUC0-∞
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sequence 1
Experimental
干预措施: ZN-A-1041 Formulation 1 (Drug)
Sequence 2
Experimental
干预措施: ZN-A-1041 Formulation 1 (Drug)
Sequence 3
Experimental
干预措施: ZN-A-1041 Formulation 1 (Drug)
Sequence 4
Experimental
干预措施: ZN-A-1041 Formulation 1 (Drug)
Sequence 5
Experimental
干预措施: ZN-A-1041 Formulation 2 (Drug)
Sequence 6
Experimental
干预措施: ZN-A-1041 Formulation 2 (Drug)
Sequence 7
Experimental
干预措施: ZN-A-1041 Formulation 2 (Drug)
Sequence 8
Experimental
干预措施: ZN-A-1041 Formulation 2 (Drug)
Sequence 5
Experimental
干预措施: Rabeprazole (Drug)
Sequence 1
Experimental
干预措施: Rabeprazole (Drug)
Sequence 2
Experimental
干预措施: Rabeprazole (Drug)
Sequence 3
Experimental
干预措施: Rabeprazole (Drug)
Sequence 4
Experimental
干预措施: Rabeprazole (Drug)
Sequence 6
Experimental
干预措施: Rabeprazole (Drug)
Sequence 7
Experimental
干预措施: Rabeprazole (Drug)
Sequence 8
Experimental
干预措施: Rabeprazole (Drug)
结局指标
主要结局
Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax, AUC0-t, and AUC0-∞
时间窗: Days 1 to 8, 11 to 14, and 17 to 20
Maximum Observed Concentration (Cmax)
时间窗: Days 1 to 8, 11 to 14, and 17 to 20
Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t)
时间窗: Days 1 to 8, 11 to 14, and 17 to 20
Maximum Observed Concentration (Cmax)
时间窗: Days 1 to 8, 11 to 14, and 17 to 20
Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t)
时间窗: Days 1 to 8, 11 to 14, and 17 to 20
AUC Extrapolated to Infinity (AUC0-∞)
时间窗: Days 1 to 8, 11 to 14, and 17 to 20
Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax, AUC0-t, and AUC0-∞
时间窗: Days 1 to 8, 11 to 14, and 17 to 20
次要结局
- Severity of AEs, Including SAEs and AESIs(Up to approximately 8.5 weeks)
- ZN-A-1041 PK Parameters Time to Maximum Observed Concentration (Tmax) for All Treatments(Days 1 to 8, 11 to 14, and 17 to 20)
- ZN-A-1041 Apparent Terminal Elimination Half-life (t1/2) for All Treatments(Days 1 to 8, 11 to 14, and 17 to 20)
- Number of Participants with Abnormalities in Clinical Laboratory Results(Baseline, Days 2, 4, 6, 10, 16, and 20)
- Changes from Baseline in Pulse Rate Measurements(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Changes from Baseline in Diastolic Blood Pressure Measurements(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Changes from Baseline in 12-lead Electrocardiogram (ECG) Parameters (RR, PR, QRS, and QT Duration)(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Changes from Baseline in 12-lead ECG Parameters (Heart Rate)(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- ZN-A-1041 PK Parameters Time to Maximum Observed Concentration (Tmax) for All Treatments(Days 1 to 8, 11 to 14, and 17 to 20)
- ZN-A-1041 Apparent Terminal Elimination Rate Constant (λz) for All Treatments(Days 1 to 8, 11 to 14, and 17 to 20)
- ZN-A-1041 Apparent Terminal Elimination Half-life (t1/2) for All Treatments(Days 1 to 8, 11 to 14, and 17 to 20)
- ZN-A-1041 Apparent Systemic Clearance (CL/F) for All Treatments(Days 1 to 8, 11 to 14, and 17 to 20)
- ZN-A-1041 Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for All Treatments(Days 1 to 8, 11 to 14, and 17 to 20)
- Incidence of Adverse Events (AEs), Including Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)(Up to approximately 8.5 weeks)
- Severity of AEs, Including SAEs and AESIs(Up to approximately 8.5 weeks)
- Number of Participants with Abnormalities in Clinical Laboratory Results(Baseline, Days 2, 4, 6, 10, 16, and 20)
- Changes from Baseline in Oral Temperature Measurements(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Columbia Suicide Severity Rating Scale (C-SSRS) Questionnaires(Baseline, Day 1, 5, 11, 17, and 20)
- Changes from Baseline in Respiratory Rate Measurements(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Changes from Baseline in Systolic Blood Pressure Measurements(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Changes from Baseline in Pulse Rate Measurements(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Changes from Baseline in Diastolic Blood Pressure Measurements(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Changes from Baseline in 12-lead Electrocardiogram (ECG) Parameters (RR, PR, QRS, and QT Duration)(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Changes from Baseline in 12-lead ECG Parameters (Heart Rate)(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Changes from Baseline in 12-lead ECG Parameters (Sinus Rhythm)(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
- Changes from Baseline in 12-lead ECG Parameters (QTcF)(Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20)
研究者
研究点 (2)
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