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

F

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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