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Trial record 1 of 1 for:    To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
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To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02690727
Recruitment Status : Completed
First Posted : February 24, 2016
Results First Posted : June 16, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: RP6530 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RP6530 in fast condition
A single dose of RP6530 following fast condition
Drug: RP6530
Single oral dose
Other Name: 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 Name: A dual PI3K delta/gamma inhibitor




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690727


Locations
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Canada
Algorithme Pharma Inc
Quebec, Canada, H3P 3P1
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
Investigators
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Principal Investigator: Eric Sicard, M.D Algorithme Pharma Inc
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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02690727    
Other Study ID Numbers: RP6530-1501
ISI-P5-416 ( Other Identifier: Algorithme Pharma Inc. )
First Posted: February 24, 2016    Key Record Dates
Results First Posted: June 16, 2017
Last Update Posted: November 28, 2017
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rhizen Pharmaceuticals SA:
Fasting
Fed condition
Pharmacokinetics