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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: FDL169


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen A<br>FDL169 200 mg reference tablet | Drug: FDL169<br>* CFTR corrector<br>|
| Experimental: Regimen B<br>FDL169 200 mg testing tablet 1 | Drug: FDL169<br>* CFTR corrector<br>|
| Experimental: Regimen C<br>FDL169 200 mg testing tablet 2 | Drug: FDL169<br>* CFTR corrector<br>|
| Experimental: Regimen D<br>FDL169 200 mg testing tablet 1 or 2 with high fat diet | Drug: FDL169<br>* CFTR corrector<br>|
| Experimental: Regimen E<br>FDL169 200 mg testing tablet 1 or 2, fasted | Drug: FDL169<br>* CFTR corrector<br>|
| Experimental: Regimen F<br>FDL169 200 mg testing tablet 1 or 2, with standard diet | Drug: FDL169<br>* CFTR corrector<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 17 weeks | 
| Pharmacokinetic parameters, Cmax | The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax) | 17 weeks | 
| Pharmacokinetic parameters, Tmax | The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax) | 17 weeks | 
| Pharmacokinetic parameters, AUC | The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC) | 17 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis