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临床试验/NCT03173573
NCT03173573已完成1 期

A Five Part Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Single and Repeat Oral Doses of FDL176 in Healthy and Cystic Fibrosis (CF) Participants

Flatley Discovery Lab LLC3 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2017年6月27日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
109
试验地点
3
主要终点
Part 2, 3 and 5: Pharmacokinetic parameters, AUC
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a 5-part study of FDL176. Part 1 is a double blind, placebo-controlled, dose escalation study in healthy male participants. Part 2 is a single dose, open-label study in healthy male participants. Part 3 is a single dose, double blind, placebo-controlled study in healthy female participants. Part 4 is a randomised, double-blind, placebo-controlled, dose-escalation study in healthy male and female participants.Part 5 is a single dose, open-label study in male and female participants with CF.

详细描述

This is a 5-part study. Part 1 is a double blind, placebo-controlled, dose escalation, first-in-human study to assess the safety, tolerability and PK profiles following single oral administration of FDL176 to healthy male participants. Part 2 is a single dose, open-label study in healthy male participants to determine the effect of food on the PK profile of FDL176. Part 3 is a single dose, double blind, placebo-controlled study in healthy female participants to assess the PK, safety and tolerability profiles of FDL176. Part 4 is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK profiles following multiple oral administrations of FDL176 to healthy male and female participants. Part 5 is a single dose, open-label study in male and female participants with CF to determine the PK profile of FDL176.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Part 1,3,4: Double blind; Part 2, 5: open label.

入排标准

年龄范围
18 Years 至 55 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Part 1 SAD FDL176 level 1 to 6

Experimental

Part 1: Single dose of FDL176 test formulation Level 1 to 6 on healthy males.

干预措施: FDL176 (Drug)

Part 1 SAD Placebo

Placebo Comparator

Part 1: Single dose of Placebo for FDL176.

干预措施: Placebo (Drug)

Part 2 SAD FDL176 at fasted state

Experimental

Part 2: single dose of FDL176 test formulation, fasted state.

干预措施: FDL176 (Drug)

Part 2 SAD FDL176 at fed state

Experimental

Part 2: single dose of FDL176 test formulation, fed state

干预措施: FDL176 (Drug)

Part 3 SAD FDL176 test formulation

Experimental

Part 3: Single dose of FDL176 test formulation on healthy females.

干预措施: FDL176 (Drug)

Part 3 SAD placebo

Placebo Comparator

Part 3: Single dose of Placebo for FDL176.

干预措施: Placebo (Drug)

Part 4 MAD FDL176 Level 1 to 3

Experimental

Part 4: Dose escalation of FDL176 test formulation Level 1 to 3.

干预措施: FDL176 (Drug)

Part 4 MAD Placebo

Placebo Comparator

Part 4: Dose escalation of Placebo for FDL176 Level 1 to 3.

干预措施: Placebo (Drug)

Part 5 SAD FDL176 test formulation

Experimental

Part 5: Single dose of FDL176 test formulation.

干预措施: FDL176 (Drug)

结局指标

主要结局

Part 2, 3 and 5: Pharmacokinetic parameters, AUC

时间窗: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks

The pharmacokinetic parameters of FDL176: area under the plasma concentration curve

Part 2, 3 and 5: Pharmacokinetic parameters, V/F

时间窗: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks

The pharmacokinetic parameters of FDL176: apparent volume of distribution

Part 1 and Part 4: Incidence of Treatment-Emergent Adverse Events.

时间窗: Part 1: 4 weeks; Part 4: 6 weeks

Part 1 and Part 4: Safety and tolerability of FDL176 in healthy male participants as determined by the incidence of adverse events (AE)s and serious adverse events(SAE)s.

Part 2, 3 and 5: Pharmacokinetic parameters, Cmax

时间窗: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks

The pharmacokinetic parameters of FDL176: maximal plasma concentration

Part 2, 3 and 5: Pharmacokinetic parameters, Tmax

时间窗: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks

The pharmacokinetic parameters of FDL176: maximal concentration

Part 2, 3 and 5: Pharmacokinetic parameters, CL/F

时间窗: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks

The pharmacokinetic parameters of FDL176: clearance

次要结局

  • Part 2, 3, and 5: Incidence of Treatment-Emergent Adverse Events.(Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks)
  • Part 1 and 4: Pharmacokinetic parameters, Cmax(Part 1: 4 weeks; Part 4: 6 weeks)
  • Part 1 and 4: Pharmacokinetic parameters,AUC(Part 1: 4 weeks; Part 4: 6 weeks)
  • Part 1 and 4: Pharmacokinetic parameters, CL/F(Part 1: 4 weeks; Part 4: 6 weeks)
  • Part 1 and 4: Pharmacokinetic parameters, V/F(Part 1: 4 weeks; Part 4: 6 weeks)
  • Part 1 and 4: Pharmacokinetic parameters,Tmax(Part 1: 4 weeks; Part 4: 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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