A Study to Assess the Safety, Tolerability and PK Profile of FDL176 in Healthy and CF Participants
- Registration Number
- NCT03173573
- Lead Sponsor
- Flatley Discovery Lab LLC
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 SAD Placebo Placebo Part 1: Single dose of Placebo for FDL176. Part 3 SAD placebo Placebo Part 3: Single dose of Placebo for FDL176. Part 4 MAD Placebo Placebo Part 4: Dose escalation of Placebo for FDL176 Level 1 to 3. Part 5 SAD FDL176 test formulation FDL176 Part 5: Single dose of FDL176 test formulation. Part 1 SAD FDL176 level 1 to 6 FDL176 Part 1: Single dose of FDL176 test formulation Level 1 to 6 on healthy males. Part 2 SAD FDL176 at fasted state FDL176 Part 2: single dose of FDL176 test formulation, fasted state. Part 2 SAD FDL176 at fed state FDL176 Part 2: single dose of FDL176 test formulation, fed state Part 3 SAD FDL176 test formulation FDL176 Part 3: Single dose of FDL176 test formulation on healthy females. Part 4 MAD FDL176 Level 1 to 3 FDL176 Part 4: Dose escalation of FDL176 test formulation Level 1 to 3.
- Primary Outcome Measures
Name Time Method Part 2, 3 and 5: Pharmacokinetic parameters, AUC 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 Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks The pharmacokinetic parameters of FDL176: apparent volume of distribution
Part 2, 3 and 5: Pharmacokinetic parameters, Cmax Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks The pharmacokinetic parameters of FDL176: maximal plasma concentration
Part 1 and Part 4: Incidence of Treatment-Emergent Adverse Events. 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, Tmax 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 Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks The pharmacokinetic parameters of FDL176: clearance
- Secondary Outcome Measures
Name Time Method Part 2, 3, and 5: Incidence of Treatment-Emergent Adverse Events. Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks 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 1 and 4: Pharmacokinetic parameters, Cmax Part 1: 4 weeks; Part 4: 6 weeks The pharmacokinetic parameters of FDL176: maximal plasma concentration
Part 1 and 4: Pharmacokinetic parameters,AUC Part 1: 4 weeks; Part 4: 6 weeks The pharmacokinetic parameters of FDL176: area under the plasma concentration curve
Part 1 and 4: Pharmacokinetic parameters, CL/F Part 1: 4 weeks; Part 4: 6 weeks The pharmacokinetic parameters of FDL176: clearance
Part 1 and 4: Pharmacokinetic parameters, V/F Part 1: 4 weeks; Part 4: 6 weeks The pharmacokinetic parameters of FDL176: apparent volume of distribution
Part 1 and 4: Pharmacokinetic parameters,Tmax Part 1: 4 weeks; Part 4: 6 weeks The pharmacokinetic parameters of FDL176: maximal concentration
Trial Locations
- Locations (3)
Linear Clinical Research
🇦🇺Perth, Western Australia, Australia
Wayne Hooper Clinic Clive Berghofer Cancer research Center
🇦🇺Herston, Queenland, Australia
Mater Hospital
🇦🇺South Brisbane, Queensland, Australia