A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects
- Registration Number
- NCT03527095
- Lead Sponsor
- Flatley Discovery Lab LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Regimen D FDL169 FDL169 200 mg testing tablet 1 or 2 with high fat diet Regimen C FDL169 FDL169 200 mg testing tablet 2 Regimen A FDL169 FDL169 200 mg reference tablet Regimen B FDL169 FDL169 200 mg testing tablet 1 Regimen E FDL169 FDL169 200 mg testing tablet 1 or 2, fasted Regimen F FDL169 FDL169 200 mg testing tablet 1 or 2, with standard diet
- Primary Outcome Measures
Name Time Method Relative bioavailability of FDL169 and its metabolites with different formulations 17 weeks To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters, Tmax 17 weeks The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax)
Incidence of Treatment-Emergent Adverse Events 17 weeks 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.
Pharmacokinetic parameters, Cmax 17 weeks The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)
Pharmacokinetic parameters, AUC 17 weeks The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC)
Trial Locations
- Locations (1)
Quotient Sciences
🇬🇧Ruddington, Nottingham, United Kingdom