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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
109
Wayne Hooper Clinic Clive Berghofer Cancer research Center
Herston, Queenland, Australia
Mater Hospital
South Brisbane, Queensland, Australia
Linear Clinical Research
Perth, Western Australia, Australia
Part 1 and Part 4: Incidence of Treatment-Emergent Adverse Events.
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.
Time frame: Part 1: 4 weeks; Part 4: 6 weeks
Part 2, 3 and 5: Pharmacokinetic parameters, Cmax
The pharmacokinetic parameters of FDL176: maximal plasma concentration
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 2, 3 and 5: Pharmacokinetic parameters, Tmax
The pharmacokinetic parameters of FDL176: maximal concentration
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 2, 3 and 5: Pharmacokinetic parameters, AUC
The pharmacokinetic parameters of FDL176: area under the plasma concentration curve
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 2, 3 and 5: Pharmacokinetic parameters, CL/F
The pharmacokinetic parameters of FDL176: clearance
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 2, 3 and 5: Pharmacokinetic parameters, V/F
The pharmacokinetic parameters of FDL176: apparent volume of distribution
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 2, 3, and 5: Incidence of Treatment-Emergent Adverse Events.
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.
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Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 1 and 4: Pharmacokinetic parameters, Cmax
The pharmacokinetic parameters of FDL176: maximal plasma concentration
Time frame: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters,Tmax
The pharmacokinetic parameters of FDL176: maximal concentration
Time frame: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters,AUC
The pharmacokinetic parameters of FDL176: area under the plasma concentration curve
Time frame: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters, CL/F
The pharmacokinetic parameters of FDL176: clearance
Time frame: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters, V/F
The pharmacokinetic parameters of FDL176: apparent volume of distribution
Time frame: Part 1: 4 weeks; Part 4: 6 weeks