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

NCT ID: NCT03527095

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2018-06-21

Brief Summary

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

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regimen A

FDL169 200 mg reference tablet

Group Type: EXPERIMENTAL

FDL169

Intervention Type: DRUG

CFTR corrector

Regimen B

FDL169 200 mg testing tablet 1

Group Type: EXPERIMENTAL

FDL169

Intervention Type: DRUG

CFTR corrector

Regimen C

FDL169 200 mg testing tablet 2

Group Type: EXPERIMENTAL

FDL169

Intervention Type: DRUG

CFTR corrector

Regimen D

FDL169 200 mg testing tablet 1 or 2 with high fat diet

Group Type: EXPERIMENTAL

FDL169

Intervention Type: DRUG

CFTR corrector

Regimen E

FDL169 200 mg testing tablet 1 or 2, fasted

Group Type: EXPERIMENTAL

FDL169

Intervention Type: DRUG

CFTR corrector

Regimen F

FDL169 200 mg testing tablet 1 or 2, with standard diet

Group Type: EXPERIMENTAL

FDL169

Intervention Type: DRUG

CFTR corrector

Interventions

FDL169

CFTR corrector

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Flatley Discovery Lab LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia Ordonez

Role: STUDY_CHAIR

Flatley Discovery Lab

Locations

Quotient Sciences

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

Other Identifiers

FDL169-2017-06

Identifier Type: -

Identifier Source: org_study_id