To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers

An Open Label, Randomized, Single Dose, Cross Over Study to Evaluate Food Effects on Relative Bioavailability of RP6530 Administered in Fasting and Fed Conditions in Healthy Volunteers

This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects. The subjects will receive the study medication under either fed or fast during each treatment period.

The present study will be conducted in healthy male volunteers. A single oral dose will be administered to the subject in each treatment period (under either fasting or fed state). Each treatment period will be separated by at least 7 calendar days. Post dose PK blood samples will be collected in each treatment period to evaluate the food effect on bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated.

Inclusion Criteria:

• Healthy male volunteers; aged 18 to 45 years;
• Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;
• Non- smokers or ex-smokers;
• Able to give informed consent.

Exclusion Criteria:

• Subjects with evidence or history of clinically significant disease;
• Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests;
• Subjects who have received any investigational drug in the previous 28 days;
• Subjects participated in a study with PI3k inhibitors at least once in past year;
• Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.