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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690727
• Other study ID #: RP6530-1501
• Secondary ID: ISI-P5-416
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2016
• Last updated: November 22, 2017
• Start date: February 2016
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: Rhizen Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• RP6530
Single oral dose

Locations

Country	Name	City	State
Canada	Algorithme Pharma Inc	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Rhizen Pharmaceuticals SA

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pharmacokinetic Parameters	Peak Plasma Concentration (Cmax)	up to 24 hours post-dose.