Clinical trial NCT03527095: A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Lead sponsor: Flatley Discovery Lab LLC
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Relative bioavailability of FDL169 and its metabolites with different formulations
timeFrame: 17 weeks
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 17 weeks
measure: Pharmacokinetic parameters, Cmax
timeFrame: 17 weeks
measure: Pharmacokinetic parameters, Tmax
timeFrame: 17 weeks
measure: Pharmacokinetic parameters, AUC
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
affiliation: Flatley Discovery Lab
name: Claudia Ordonez
role: STUDY_CHAIR
References: