A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects

Flatley Discovery Lab LLC11 enrolled

Overview

This is a randomised, cross-over study comprised of 6 periods in healthy subjects.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.

This is a single centre, randomised, cross-over study comprised of 6 periods in healthy males and females.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

FDL169DRUG

CFTR corrector

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and non-pregnant, non-lactating female subjects * Aged 18 to 55 years * Body mass index of 18.0 to 32.0 kg/m2 * Must agree to the use of an adequate method of contraception Exclusion Criteria: * Subjects who have received any IMP in a clinical research study within the previous 3 months * History of any drug or alcohol abuse in the past 2 years * Current smokers and those who have smoked within the last 12 months. * Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level \>1.5 x upper limit of normal at screening * Abnormal renal function at screening * Clinically significant abnormal biochemistry, haematology, coagulation profile or urinalysis * Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results * History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder. * Subjects with a history of gall stones or abdominal surgery eg cholecystectomy * Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients * Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedy (including known inhibitors or inducers of CYP3A4

Locations (1)

Quotient Sciences

Ruddington, Nottingham, United Kingdom

Outcomes

Primary Outcomes

Relative bioavailability of FDL169 and its metabolites with different formulations

To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet

Time frame: 17 weeks

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events

Safety and tolerability of FDL169 and its metabolites M1 and M3 , as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.

Time frame: 17 weeks

Pharmacokinetic parameters, Cmax

The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)

Time frame: 17 weeks

Pharmacokinetic parameters, Tmax

The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax)

Time frame: 17 weeks

Pharmacokinetic parameters, AUC

The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC)

Time frame: 17 weeks

Data from ClinicalTrials.gov

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