A Phase I, Double-Blind, Randomised, Placebo Controlled, Multiple-Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DS-1971a in Healthy Male and Female Subjects
概览
- 阶段
- 1 期
- 干预措施
- DS-1971a
- 疾病 / 适应症
- Healthy
- 发起方
- Daiichi Sankyo
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of participants with at least one Treatment Emergent Adverse Event (TEAEs)
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
This is a randomised, double-blind, placebo-controlled multiple dose study designed to explore the safety, tolerability and PK of DS-1971a following oral administration over 14 days to healthy male and female subjects. Each participant receives lidocaine as a local anaesthetic before inserting the intravenous cannula.
详细描述
Within strictly defined limits, the protocol permits the dose escalation committee to amend the dose escalation rules, doses proposed in the study protocol and to change the timing of or to add additional assessments following review of the safety, tolerability and plasma DS-1971a concentration data. The decisions to change the doses will be documented in the minutes of the dose escalation committee.
研究者
入排标准
入选标准
- •Healthy male and female subjects aged 18 years to 65 years.
- •A body mass index (BMI) in the range 18 kg/m2 to 30 kg/m2, inclusive, and weighing between 50 kg and 100 kg, inclusive at screening. BMI is calculated as weight \[kg\]/(height \[m\])
- •Female subjects must be of non-childbearing potential as follows:
- •Must be postmenopausal (the last menstrual period was at least 12 months before Screening, and a follicle stimulating hormone \[FSH\] test at Screening confirms postmenopausal status); or
- •Must be surgically sterile having undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy and/or bilateral tubal ligation.
- •Willing to comply with all study restrictions, including the use of contraception, concomitant medication, and dietary and lifestyle restrictions.
- •Sufficient intelligence to understand the nature of the study and any hazards of participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with requirements of, the entire study.
- •Have given written consent to participate in the study after reading the ICF, and after having the opportunity to discuss the study with the Investigator or his delegate.
- •Have given written consent to have his/her data entered into The Over volunteering Prevention System.
排除标准
- •Clinically relevant abnormal history, physical findings, ECG findings, or laboratory values that could interfere with the objectives of the study or compromise the safety of the subject.
- •Presence or history of acute or chronic illness, including (but not limited to) liver or kidney disease, hypertension, seizures, or any known impairment of endocrine, or other specific body-organ dysfunction.
- •History of serious reaction to any medicine.
- •Presence or history of malignant disease.
- •Acute or chronic infectious disease, including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or C virus (HCV) infection.
- •Surgery (eg, stomach bypass) or medical condition that might affect how the body handles or absorbs medicines.
- •Significant illness within 4 weeks before the first dose of study medication.
- •Participation in another clinical study of a new chemical entity or a prescription medicine within the previous 3 months, or unwilling to abstain from participating in other clinical trials during the study and for 3 months after receipt of study medication.
- •Blood pressure (BP) and heart rate in semi-supine position at the Screening examination outside the ranges 90 mmHg to 140 mmHg systolic, 40 mmHg to 90 mmHg diastolic; heart rate \< 40 beats/min to \> 100 beats/min. Subjects with Stage 1 hypertension (systolic 140 mmHg to 160 mmHg; diastolic 90 mmHg to 100 mmHg) may be enrolled provided they do not have evidence of end-organ damage, diabetes or a 10 year cardiovascular risk \> 20%.
- •Abnormal ECG waveform morphology at Screening that would preclude accurate measurement of the uncorrected QT interval (QT) duration.
研究组 & 干预措施
DS-1971a (Low Dose)
Participants in Cohort 1 who receive a low dose of DS 1971a in an oral suspension
干预措施: DS-1971a
DS-1971a (Mid dose)
Participants in Cohort 2 who receive a mid dose of DS 1971a in an oral suspension
干预措施: DS-1971a
DS-1971a (High dose)
Participants in Cohort 3 who receive a high dose of DS 1971a in an oral suspension
干预措施: DS-1971a
Pooled placebo
Participants in Cohort 1, 2 or 3 who receive matching DS-1971a Placebo
干预措施: Placebo
结局指标
主要结局
Number of participants with at least one Treatment Emergent Adverse Event (TEAEs)
时间窗: 14 days
TEAEs are adverse events that began or got worse after treatment began. Clinically significant changes in laboratory tests and/or physical examinations are considered adverse events.
次要结局
- Tmax of DS-1971a(Day 1 and Day 14)
- Cmax of DS-1971a(Day 1 and Day 14)
- Tmax of DS-1971a metabolites M1 and M2(Day 1 and Day 14)
- Area Under Curve at steady state (AUCtau) of DS-1971a(Day 1 and Day 14)
- Area under the Curve (additional measures) for DS-1971a(Day 1 and Day 14)
- Cmax of DS-1971a metabolites M1 and M2(Day 1 and Day 14)
- AUC of DS-1971a metabolites M1 and M2(Day 1 and Day 14)