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

Flatley Discovery Lab

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: FDL169

Study type: Interventional

Funder types: Other

Identifiers

NCT03527095

FDL169-2017-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 6 patient groups

Regimen A

Experimental group

Description:

FDL169 200 mg reference tablet

Treatment:

Drug: FDL169

Regimen B

Experimental group

Description:

FDL169 200 mg testing tablet 1

Treatment:

Drug: FDL169

Regimen C

Experimental group

Description:

FDL169 200 mg testing tablet 2

Treatment:

Drug: FDL169

Regimen D

Experimental group

Description:

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

Treatment:

Drug: FDL169

Regimen E

Experimental group

Description:

FDL169 200 mg testing tablet 1 or 2, fasted

Treatment:

Drug: FDL169

Regimen F

Experimental group

Description:

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

Treatment:

Drug: FDL169