Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will be randomized to sequentially receive both sublingual and oral formulations of FDL169.
This is a single center, open label study on healthy volunteers. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data. Part 1 and optional Part 2 have randomized, 2 period crossover designs. Subjects will randomized to 1 of 2 treatment sequences in order to receive 2 single doses of FDL169 on separate occasions, one as a sublingual administration and one as an oral administration. There will be a minimum washout period of 10 days between FDL169 administrations. The duration of each part is approximately 7 weeks from screening to follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Cystic Fibrosis Transmembrane Regulator (CFTR) corrector
Quotient Sciences
Nottingham, United Kingdom
Pharmacokinetic parameters, Cmax
The pharmacokinetic parameters of FDL169; maximal plasma concentration (Cmax)
Time frame: 7 weeks
Pharmacokinetic parameters, Tmax
The pharmacokinetic parameters of FDL169; maximal concentration (Tmax)
Time frame: 7 weeks
Pharmacokinetic parameters, AUC
The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC)
Time frame: 7 weeks
Pharmacokinetic parameters, CL/F
The pharmacokinetic parameters of FDL169; clearance (CL/F)
Time frame: 7 weeks
Pharmacokinetic parameters, V/F
The pharmacokinetic parameters of FDL169; apparent volume of distribution (V/F)
Time frame: 7 weeks
Ratio of pharmacokinetic parameters, AUC, between sublingual and oral formulation
The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC) of FDL169 and its M1 metabolite following sublingual dosing compared to oral dosing
Time frame: 7 weeks
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability of FDL169 as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.
Time frame: 7 weeks
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