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

Launched by FLATLEY DISCOVERY LAB LLC · May 15, 2018

Keywords

ClinConnect Summary

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.

Gender

ALL

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