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

• Status: Completed
• Trial end date: 2018-06-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Flatley Discovery Lab LLC

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