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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: RP6530


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RP6530 in fast condition<br>A single dose of RP6530 following fast condition | Drug: RP6530<br>* Single oral dose<br>* Other names: A dual PI3K delta/gamma inhibitor;|
| Experimental: RP6530 in fed condition<br>A single dose of RP6530 following fed condition | Drug: RP6530<br>* Single oral dose<br>* Other names: A dual PI3K delta/gamma inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC)) | Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state. | up to 24 hours post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Were Evaluated for Adverse Events | Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0 | 7 days | 
| Pharmacokinetic Parameters | Peak Plasma Concentration (Cmax) | up to 24 hours post-dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fed condition, Fasting, Pharmacokinetics