ACTRN12624001072505尚未招募1 期
A Phase 1 Drug-Drug Interaction Study to Assess the Interaction Potential of NB-4746 on CYP1A2 and CYP3A4 Substrates in Healthy Volunteers
ura Bio0 个研究点目标入组 18 人开始时间: 2024年9月5日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Participants will be eligible to be included in the study if all of the following criteria apply:
- •1.Aged greater or equal to 18 years and less than or equal to 65 years.
- •2.Body mass index (BMI) within the range 18 to 30 kg per m2 (inclusive).
- •3.Overtly healthy, as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (ECG) obtained at screening and Day 1.
- •4.Baseline (screening and Day -1) laboratory test values within normal ranges. Out of normal range values may be accepted by the Investigator, if not clinically significant, with the exception of the following:
- •a.Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than 1.5 x upper limit of normal.
- •b.Total, indirect, or direct bilirubin greater than 1.5 x upper limit of normal. Participants with Gilbert’s syndrome with indirect bilirubin outside of the normal range will be excluded from the study.
- •c.Creatinine clearance less than 80 mL per min (estimated from Cockcroft Gault equation).
- •d.Amylase and lipase must be within the normal range at screening and Day -1.
- •5.Nonsmoker and or ex-smoker who has discontinued smoking and or use of nicotine-containing products (including nicotine and non-nicotine vapes) for at least 3 months prior to the first dose of study drug, confirmed by a negative carbon monoxide (CO) breath test at screening and Day -1.
- •6.Willing to refrain from consumption of caffeine-containing products including, but not limited to, coffee, tea, cola drinks, and chocolate for at least 48 hours prior to the first dose of study drug through to discharge on Day 14.
- •7.Females must be either amenorrheic for greater than or equal to 1 year or with FSH greater than 40 mIU/mL at screening if amenorrheic less than 1 year); or surgically sterile (having undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months. However, to protect against the transfer of the study drug in any bodily fluids, male partners of female participants (whether postmenopausal or surgically sterile) must use a barrier form (e.g., condom) of contraception until the EOS visit or 7 days after the last dose of study drug in case of early study termination.
- •8.Males with female partners of childbearing potential must agree to use barrier contraceptive (i.e., condom) and their female partners must use a highly effective method of contraception from screening to 90 days after the last dose of study drug. Males must also refrain from sperm donations during this time period. Males who are abstinent will not be required to use a contraceptive method unless they become sexually active. Males in a same sex relationship must also use a barrier form of contraception against the transfer of the study drug in any bodily fluids until the End of Study visit or 7 days after the last dose of study drug in case of early termination.
- •9.Capable of giving signed informed consent.
- •10.Ability to communicate well with the Investigator, in the local language, and to understand and comply with the requirements of the study.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1.History or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs; or interfering with the interpretation of data.
- •2.History of pancreatitis or with prior cholecystectomy.
- •3.Any history of significant medical illness or any chronic medical illness, as determined by the investigator.
- •4.Mentally or legally incapacitated, has significant emotional problems at screening or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years. Note: normal healthy volunteers who have had situational depression may be enrolled in the study at the discretion of the Investigator.
- •5.History of severe drug allergy or hypersensitivity or food allergy, including anaphylaxis.
- •6.Has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study drug.
- •7.Has donated more than 1 unit (500 mL) of blood within 4 weeks prior to the first dose of study drug.
- •8.Fever (body temperature greater than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening.
- •9.Abnormal heart rate or blood pressure (mean resting heart rate less than or equal to 40 or greater than or equal to 100 bpm, systolic BP less than or equal to 90 or greter than or equal to 149 mmHg, diastolic BP less than or equal to 50 to greater than or equal to 90 mmHg) at screening or before the first administration of study drug. Vitals may be repeated up to 2 times for the purpose of eligibility.
- •10.Any other abnormal vital signs that are considered to be clinically significant by the investigator.
- •11.Lifetime history of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. Fully resected basal cell carcinoma and squamous cell carcinoma with no evidence of recurrence for 1 year are permitted.
- •12.QTcF interval (QT with Fridericia’s correction) greater than 450 msec in males and greater than 470 msec in females at screening, or any other ECG finding that is considered to be clinically significant by the investigator.
- •13.Inability to swallow or tolerate oral medications.
- •14.Past or intended use of over-the-counter or prescription medication (including herbal medications) within 14 days before Day 1, with the exception of occasional paracetamol (doses up to 2 g per day for no more than 3 consecutive days).
- •15.Live vaccine(s) within 1 month before screening or plans to receive such vaccines during the study.
- •16.Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) before Day 1.
- •17.Current participation in any other investigational drug study or receipt of an investigational drug within 30 days or 5 half-lives (whichever is longer) before Day 1.
- •18.Regular use of known drugs of abuse or a history of drug abuse within 12 months prior to screening or positive screening or Day -1 drugs of abuse test.
- •19.Regular alcohol consumption within 6 months before the study, current evidence of substance dependence or self-reported alcoholic intake >2 drinks/day for
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