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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: RP6530

• Registration Number: NCT02690727
• Lead Sponsor: Rhizen Pharmaceuticals SA

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted: 2016-02-15
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2016-12-15
• Results First Submitted QC: 2017-04-03
• Results First Posted: 2017-06-16
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RP6530 in fast condition	RP6530	A single dose of RP6530 following fast condition
RP6530 in fed condition	RP6530	A single dose of RP6530 following fed condition

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Algorithme Pharma Inc; 🇨🇦 Quebec, Canada