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

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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Drug: FDL169

Detailed Description

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
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Flatley Discovery Lab LLC
• Investigators: Study Chair: Claudia Ordonez, Flatley Discovery Lab

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): June 21, 2018
• Study Completion (Actual): June 21, 2018

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Cystic Fibrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: FDL169-2017-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No