A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation First-Time-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Part 1B: food effect on the tolerability of FDL169 for 48 h following a single dose
研究概览
简要总结
To determine the safety and tolerability of single and multiple escalating doses of FDL169 in healthy male subjects.
详细描述
This study is the first time in human study and consists of two parts.
Part 1A:
Part 1 of the study is a randomised, double-blind, placebo-controlled, dose-escalation, first-time-in-human study to assess the safety, tolerability and PK profiles following single oral administrations of FDL169 to healthy male volunteers. Sixty-four (64) male subjects (8 per cohort) will be included in Part 1 of the study. Up to eight dose levels of FDL169 are planned to be tested in Part 1 of the study.
Part 1B:
Open label. Following completion of Part 1A of the study, an additional cohort of 8 subjects will receive a single dose of FDL169 in both fasted and fed states
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 18 to 45 years who fulfil standard safety screening assessments for the study (haematology/biochemistry, urinalysis, 12-lead electrocardiogram (ECG), vital signs and oral temperature) and who in the opinion of the Investigator, are medically suitable to participate in the study. Male subjects and their partners must be willing to use an effective method of contraception from first dose of investigational medicinal product (IMP) and for 3 months after the last dose of IMP.
排除标准
- •Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months.
- •Subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (endocrine or immunologic disease), at Screening.
- •Donation of 500 mL or more blood within the previous 3 months.
- •Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 21 days (or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Flatley Discovery Labs Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- •Smoking or use tobacco products or substitutes equivalent to > 15 cigarettes/day.
- •Any subject attempting to father a child within 3 months of their Follow-Up Visit.
研究组 & 干预措施
Placebo single dose
Placebo administered as a single dose
干预措施: Placebo (Drug)
Single dose (Dose level 1)
FDL169 (Dose level 1) administered as a single dose
干预措施: FDL169 (Drug)
Single dose (Dose level 2)
FDL169 (Dose level 2) administered as a single dose
干预措施: FDL169 (Drug)
Single dose (Dose level 3)
FDL169 (Dose level 3) administered as a single dose
干预措施: FDL169 (Drug)
Single dose (Dose level 4)
FDL169 (Dose level 4) administered as a single dose
干预措施: FDL169 (Drug)
Single dose (Dose level 5)
FDL169 (Dose level 5) administered as a single dose
干预措施: FDL169 (Drug)
Single dose (Dose level 6)
FDL169 (Dose level 6) administered as a single dose
干预措施: FDL169 (Drug)
Single dose (Dose level 7)
FDL169 (Dose level 7) administered as a single dose
干预措施: FDL169 (Drug)
Single dose (Dose level 8)
FDL169 (Dose level 8) administered as a single dose
干预措施: FDL169 (Drug)
Additional single dose 1
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
干预措施: FDL169 (Drug)
Additional single dose 2
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
干预措施: FDL169 (Drug)
Additional single dose 3
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
干预措施: FDL169 (Drug)
Additional single dose 4
Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
干预措施: FDL169 (Drug)
Food effect - fasted
Single dose of FDL169 in fasted conditions
干预措施: FDL169 (Drug)
Food effect - fed
Single dose of FDL169 in fed conditions
干预措施: FDL169 (Drug)
Placebo - multiple dose
Repeat doses of placebo
干预措施: Placebo (Drug)
Multiple dose - Dose level 1
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
干预措施: FDL169 (Drug)
Multiple dose - Dose level 2
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
干预措施: FDL169 (Drug)
Multiple dose - Dose level 3
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
干预措施: FDL169 (Drug)
Multiple dose - Dose level 4
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
干预措施: FDL169 (Drug)
Multiple dose - additional dose level 1
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
干预措施: FDL169 (Drug)
Multiple dose - additional dose level 2
Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)
干预措施: FDL169 (Drug)
结局指标
主要结局
Part 1B: food effect on the tolerability of FDL169 for 48 h following a single dose
时间窗: Multiple points from screening to follow-up (up to 42 days)
Vital signs, ECG, safety laboratory data and AEs
Part 2: safety and tolerability following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose) (Vital signs, ECG, safety laboratory data and AEs)
时间窗: Multiple points from screening to follow-up (up to 42 days)
Vital signs, ECG, safety laboratory data and AEs
Part 1A: safety and tolerability for 48 h following single oral doses of FDL169 (Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)
时间窗: Multiple points from screening to follow-up (up to 28 days)
Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)
Part 1B: food effect on the pharmacokinetics of FDL169 for 48 h following a single dose
时间窗: Multiple points from pre-dose to 48 h post-dose
Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated
次要结局
- Part 1: pharmacokinetic profile for 48 h following single oral doses of FDL169(Multiple points from pre-dose to 48 h post-dose)
- Part 2: pharmacokinetic profile following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose)(Multiple points from pre-dose to 24 h post-dosing on Day 14)