Skip to main content
OpenTrials
Completed

NCT Number: NCT02690727

To Evaluate the Food Effect on Relative Bioavailability of RP6530 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Behavior Fasting Feeding Behavior

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Algorithme Pharma Inc

Québec, H3P 3P1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RP6530

Drug

Single oral dose

Other names: A dual PI3K delta/gamma inhibitor

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Pharmacokinetic Parameters

    Time frame: up to 24 hours post-dose.

    Peak Plasma Concentration (Cmax)

Sponsors and collaborators

Lead sponsor

Rhizen Pharmaceuticals SA

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 24, 2016
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.