A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Escalating Dose Trial in Healthy Participants to Assess Pharmacokinetics, Safety, and Tolerability of TEV-56286 at Clinical and Supratherapeutic Doses
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- SAD: Time to maximum observed plasma drug concentration (tmax) of TEV-56286
研究概览
简要总结
The purpose of the trial is to evaluate the pharmacokinetics, safety, and tolerability of TEV-56286 at different doses.
The main objective is to describe how TEV-56286 is absorbed, distributed, and removed from the body (the pharmacokinetics) following administration of TEV-56286 in single doses of increasing amounts and multiple doses in healthy participants.
A secondary objective is to assess the safety of TEV-56286 and how well it is tolerated.
The estimated duration for participants in Part 1 with Single Ascending Dose is approximately 58 days; including up to 45 days of screening, a 4-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.
The estimated duration for participants in Part 2 with Multiple Ascending Dose is approximately 64 days; including up to 45 days of screening, a 10-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is a healthy male or female with a body weight of ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) of 18.5 to 32.0 kg/m2 inclusive.
- •Participant is 18 to 60 years of age inclusive, at the time of signing the informed consent form (ICF).
- •Female participants are eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:
- •A woman of non-child bearing potential (WONCBP) as defined: Female participants who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile, or at least 1 year postmenopausal (no menses for at least 12 months without an alternative medical cause plus an increased concentration of follicle stimulating hormone [FSH] within the menopausal range in women not using hormonal contraception or hormonal replacement therapy).
- •A woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), used consistently and correctly. The acceptable contraceptive regimens in this trial are: non-hormonal intrauterine device (IUD) used for at least 2 consecutive months prior to dosing and willing to continue until at least 28 days after last dose of investigational medicinal product (IMP), bilateral tubal occlusion, and/or azoospermic partner (vasectomized or due to a medical cause). A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of IMP. The participant must be excluded from participation if the serum pregnancy result is positive.
- •Male participants are eligible to participate if they are azoospermic (vasectomized or due to a medical cause) or, alternatively, agree to the following during the trial period, from admission (day -1) and for at least 28 days after last dose of IMP.
- •Refrain from donating sperm, in addition to following:
- •EITHER be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
- •OR must agree to use contraception/barrier as detailed below:
- •Agree to use a male condom with female partner using an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a WOCBP who is not currently pregnant.
- •Agree to use a male condom when having sexual intercourse with a pregnant partner.
- •NOTE-Additional criteria apply, please contact the investigator for more information
排除标准
- •Participant presents with or has a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal system, or presence/history of clinically significant immunological, endocrine, metabolic diseases, neurological, psychiatric, or immunological disorder(s), or a history of any illness that, in the opinion of the Principal Investigator, might pose additional risk to the participant by participation in the trial or confound the results of the trial.
- •Participant presents with a major trauma or surgery during the 60 days prior to screening or at any time between screening and the first dose of IMP, or surgery scheduled during the trial including follow-up period.
- •The participant has a history of any malignant disease (except for treated and cured skin basal cell carcinoma at least 12 months prior to screening).
- •Participant has a known drug hypersensitivity reaction to the active component of IMP, or one of its excipients, or any compound listed as being present in a trial formulation.
- •Participant has a personal or family history of arrhythmia, long QT syndrome, or sudden unexplained death in a first-degree relative before the age of 40; or personal history of syncope, myocardial infarction, cerebrovascular accident, or previous treatment for high blood pressure (BP).
- •Participant has an alkaline phosphatase (ALP), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), or total bilirubin above the upper limit of normal (ULN).
- •Participant has a history of alcohol, drug, or any other substance dependence (with the exception of nicotine or caffeine) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (American Psychiatric Association 2013) or are unwilling to comply with the restricted food or beverages during the trial.
- •Participant is a current smoker, has smoked in the last 6 months, is planning to start smoking during the trial, uses tobacco, or uses other nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, e-cigarettes, vaping devices, inhalers), or has a positive urine cotinine test.
- •NOTE-Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
Group 1: Single Ascending Dose (SAD1)
干预措施: Placebo (Drug)
Group 6: Multiple Ascending Dose (MAD2)
干预措施: Placebo (Drug)
Group 2: Single Ascending Dose (SAD2)
干预措施: TEV-56286 (Drug)
Group 4: Single Ascending Dose (SAD4)
干预措施: TEV-56286 (Drug)
Group 3: Single Ascending Dose (SAD3)
干预措施: TEV-56286 (Drug)
Group 5: Multiple Ascending Dose (MAD1)
干预措施: TEV-56286 (Drug)
Group 1: Single Ascending Dose (SAD1)
干预措施: TEV-56286 (Drug)
Group 6: Multiple Ascending Dose (MAD2)
干预措施: TEV-56286 (Drug)
Group 2: Single Ascending Dose (SAD2)
干预措施: Placebo (Drug)
Group 3: Single Ascending Dose (SAD3)
干预措施: Placebo (Drug)
Group 4: Single Ascending Dose (SAD4)
干预措施: Placebo (Drug)
结局指标
主要结局
SAD: Time to maximum observed plasma drug concentration (tmax) of TEV-56286
时间窗: Day 1 to Day 3
SAD: Maximum observed plasma concentration (Cmax) of TEV-56286
时间窗: Day 1 to Day 3
SAD: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of TEV-56286
时间窗: Day 1 to Day 3
SAD: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of TEV-56286
时间窗: Day 1 to Day 3
MD: tmax of TEV-56286
时间窗: Day 7 to Day 9
MD: Cmax of TEV-56286
时间窗: Day 7 to Day 9
MD: AUC0-t of TEV-56286
时间窗: Day 7 to Day 9
MD: Area Under the Plasma Drug Concentration-Time Curve for the Defined Interval Between Doses (AUC0-tau) of TEV-56286
时间窗: Day 7 to Day 8
MAD: tmax of TEV-56286
时间窗: Day 7 to Day 9
MAD: Cmax of TEV-56286
时间窗: Day 7 to Day 9
MAD: AUC0-t of TEV-56286
时间窗: Day 7 to Day 9
MAD: Area Under the Plasma Drug Concentration-Time Curve for the Defined Interval Between Doses (AUC0-tau) of TEV-56286
时间窗: Day 7 to Day 8
次要结局
- Number of participants with at least 1 treatment-emergent adverse event(Up to Day 17)
- Number of participants who did not complete the trial due to an adverse event(Up to Day 17)