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

November 22, 2017 updated by: Rhizen Pharmaceuticals SA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, H3P 3P1
        • Algorithme Pharma Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RP6530 in fast condition
A single dose of RP6530 following fast condition
Drug: RP6530
Single oral dose
Other Names:
  • A dual PI3K delta/gamma inhibitor
Experimental: RP6530 in fed condition
A single dose of RP6530 following fed condition
Drug: RP6530
Single oral dose
Other Names:
  • A dual PI3K delta/gamma inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))
Time Frame: 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.
up to 24 hours post-dose.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhizen Pharmaceuticals SA

Investigators

  • Principal Investigator: Eric Sicard, M.D, Algorithme Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP6530-1501
  • ISI-P5-416 (Other Identifier: Algorithme Pharma Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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