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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

Tracking Information
First Submitted Date  ICMJE February 15, 2016
First Posted Date  ICMJE February 24, 2016
Results First Submitted Date  ICMJE December 15, 2016
Results First Posted Date  ICMJE June 16, 2017
Last Update Posted Date November 28, 2017
Study Start Date  ICMJE February 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) [ Time Frame: up to 24 hours post-dose. ]
AUC0-T of RP6530 in fed and fast state.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
  • 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
  • Pharmacokinetic Parameters [ Time Frame: up to 24 hours post-dose. ]
    Peak Plasma Concentration (Cmax)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 7 days ]
    Adverse events (AE's), clinical laboratory tests, vital signs, physical examination and 12 lead ECG.
  • Pharmacokinetic parameters (Peak Plasma Concentration (Cmax)) [ Time Frame: up to 24 hours post-dose. ]
    Peak Plasma Concentration (Cmax)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: RP6530
Single oral dose
Other Name: A dual PI3K delta/gamma inhibitor
Study Arms  ICMJE
  • Experimental: RP6530 in fast condition
    A single dose of RP6530 following fast condition
    Intervention: Drug: RP6530
  • Experimental: RP6530 in fed condition
    A single dose of RP6530 following fed condition
    Intervention: Drug: RP6530
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2016)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02690727
Other Study ID Numbers  ICMJE RP6530-1501
ISI-P5-416 ( Other Identifier: Algorithme Pharma Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rhizen Pharmaceuticals SA
Study Sponsor  ICMJE Rhizen Pharmaceuticals SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Sicard, M.D Algorithme Pharma Inc
PRS Account Rhizen Pharmaceuticals SA
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP