A Phase 1, Randomised, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Systemic Bioavailability of Oral OTS167 Under Fed and Fasting Conditions in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Half life (T1/2)
研究概览
简要总结
The purpose of this study is to determine the indicative bioavailability of a single oral dose of OTS167, and to evaluate the effects of food on OTS167 pharmacokinetics (PK) after oral dosing.
Eleven male and female healthy participants aged 45 years and over will be entered into this phase 1, single-centre, double-blind, randomised, cross-over study. The trial is designed to evaluate the bioavailability of OTS167, and the effects of food on pharmacokinetics (PK) of OTS167 when administered by the oral route. Correlative studies include evaluation of safety endpoints and examinations, and adverse events. This study involves 3 cohorts to evaluate the safety and tolerability of oral dosing from lower dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must meet all of the following criteria to be eligible for participation in the study:
- •Males or females aged 45 years or over.
- •Female participants of non-childbearing potential, meeting at least one of the following criteria:
- •Amenorrhoeal for 12 months (menopause confirmed by Follicular Stimulating Hormone (FSH) and Luteinising Hormone (LH) levels as defined by the established reference ranges), or
- •Surgically sterile (e.g. hysterectomy, oophorectomy, tubal ligation) for at least the past 3 month.
- •Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form (ICF).
- •Able and willing to comply with the protocol, including availability for all scheduled study visits.
- •Body mass index (BMI) 18 kg/m2 to 30 kg/m2 (inclusive)
- •No clinically significant abnormalities as determined by medical history, physical examination, blood chemistry, hematology, urinalysis, and 12-lead electrocardiogram (ECGs).
- •If male, agrees to use a medically acceptable method of contraception from Screening until 7 days after administration of the last dose of study drug. Medically acceptable methods of contraception include the following: abstinence; medically approved hormonal methods; condom; diaphragm; and intrauterine device. This requirement may be waived if the Principal Investigator or delegate is satisfied that the participant or partner is sterile (i.e., if female has undergone a hysterectomy, or has undergone a tubal ligation at least 3 months prior to Screening, or is postmenopausal [no menstrual period for at least 12 months prior to Screening]; if male, has undergone vasectomy at least 6 months prior to Screening). Male participants agree not to donate sperm for at least 90 days [3 months] after administration of the last dose of study drug.
- •Agree to avoid drinking alcohol within 72 hours prior to check-in to the clinical facility.
- •Adequate venous access in the left and right arm to allow collection of a number of blood samples.
排除标准
- •Participants meeting any of the following criteria are ineligible for participation in the study.
- •Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases
- •Orthostatic blood pressure changes (>15mmHg) or symptoms, or presence of uncontrolled hypertension (SBP >160 mmHg or diastolic >95 mmHg) at screening, admission (Day -1) or pre-dose (Day 1).
- •Greater than 2 standard drinks per day, on average, for men and women, or any history of drug or alcohol addiction or abuse within the last 5 years.
- •History of allergic, anaphylaxis or hypersensitivity to OTS167 or excipients or contents of Humco ™ cherry syrup.
- •Female participants who are currently lactating.
- •Donated either blood or plasma (e.g., plasmapheresis) within 6 weeks prior to dosing in Period
- •All participants must be advised not to donate either blood or plasma for at least 6 weeks after completing the study.
- •Use of prescription medications (with the exception of contraceptives), over-the-counter medications (with the exception of paracetamol [< 2 gm/day] or single-dose daily multivitamins), or herbal medications or products containing herbal extracts within 14 days prior to the first dose.
- •Positive results on illicit drug test or alcohol breath test at screening or at admission.
- •Positive screening test for HIV antibodies, Hepatitis B surface antigen or Hepatitis C antibody.
- •Use of any investigational drug within the last 30 days or within a period of 5 times the drug's half-life, whichever is longer, or current participation in any investigational protocol.
- •Participants who, in the opinion of the Principal Investigator or delegate, should not participate in the study or are not capable of following the study schedule for any reason.
- •Either QTcF >450 or HR <40 or >100 at screening, admission (Day-1) or pre-dose (Day 1). Test may be repeated at discretion of investigator to obtain average in order to confirm eligibility.
研究组 & 干预措施
OTS167IV
Cohort 1: 0.5 mg, Cohort 2: 1.0 mg, and Cohort 3: 2.0 mg without food on Period 1 Day 1 and with food on Day 1 Period 2.
干预措施: OTS167IV (Drug)
Placebo
Cherry syrup
干预措施: Cherry syrup (Other)
结局指标
主要结局
Half life (T1/2)
时间窗: 24 hours after final study drug administration.
Safety: Participants to be monitored throughout the treatment and follow-up period for occurrence of adverse events (AEs) (acute, delayed, and/or cumulative), as well as for changes in clinical status, vital signs, and laboratory data.
时间窗: 7 days after final study drug administration.
Safety assessments include concomitant medication survey, adverse events, temperature, pulse and respiratory rate, blood pressure, physical examination, hematologic parameters, serum chemistries, coagulation parameters, urinalyses, and 12-Lead ECG and cardiac telemetry.
Maximum Plasma Concentration (Cmax)
时间窗: 24 hours after final study drug administration.
Time of Maximum concentration (Tmax)
时间窗: 24 hours after final study drug administration.
Area Under the Curve (AUC)
时间窗: 24 hours after final study drug administration.
次要结局
未报告次要终点