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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: RP6530
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RP6530: Fast Condition First, Then Fed Condition RP6530: Fed Condition First, Then Fast Condition
Hide Arm/Group Description

Fast Condition first, then Fed Condition

RP6530: Single oral dose

Fed Condition first, then Fast Condition

RP6530: Single oral dose

Period Title: Overall Study
Started 9 9
Completed 7 7
Not Completed 2 2
Reason Not Completed
Adverse Event             2             2
Arm/Group Title All Participants
Hide Arm/Group Description

A single dose of RP6530 following fasting and Fed condition

RP6530: Single oral dose

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
18 healthy volunteers were enrolled to get at least 12 completed subjects to demonstrate food effect. Safety population included all participants who received at least 1 dose of study drug. PK population included all the participants who provided PK in both period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
29  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
0
   0.0%
Male
18
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
3
  16.7%
Not Hispanic or Latino
15
  83.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
01
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
16
  88.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 18 participants
18
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 18 participants
73.9  (8.1)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 18 participants
173.7  (7.2)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 18 participants
24.50  (2.46)
1.Primary Outcome
Title Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))
Hide Description Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.
Time Frame up to 24 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
subjects who provided evaluable data for both treatments (Fasting and fed conditions)
Arm/Group Title RP6530 in Fast Condition RP6530 in Fed Condition
Hide Arm/Group Description:

A single dose of RP6530 following fast condition

RP6530: Single oral dose

A single dose of RP6530 following fed condition

RP6530: Single oral dose

Overall Number of Participants Analyzed 14 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per millilitre (ng*h/mL)
5277.01
(33.4%)
6726.99
(29.4%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RP6530 in Fast Condition, RP6530 in Fed Condition
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (%)
Estimated Value 128.49
Confidence Interval (2-Sided) 90%
119.13 to 138.59
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Were Evaluated for Adverse Events
Hide Description Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy volunteers
Arm/Group Title RP6530 in Fast Condition RP6530 in Fed Condition
Hide Arm/Group Description:

A single dose of RP6530 following fast Condition

RP6530: Single oral dose

A single dose of RP6530 following fed Condition

RP6530: Single oral dose

Overall Number of Participants Analyzed 16 16
Measure Type: Count of Participants
Unit of Measure: Participants
16
 100.0%
16
 100.0%
3.Secondary Outcome
Title Pharmacokinetic Parameters
Hide Description Peak Plasma Concentration (Cmax)
Time Frame up to 24 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who provided evaluable data for both treatments
Arm/Group Title RP6530 in Fast Condition RP6530 in Fed Condition
Hide Arm/Group Description:

A single dose of RP6530 following fast condition

RP6530: Single oral dose

A single dose of RP6530 following fed condition

RP6530: Single oral dose

Overall Number of Participants Analyzed 14 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per millilitre (ng/mL)
1311.77
(42.0%)
1753.78
(32.6%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RP6530 in Fast Condition, RP6530 in Fed Condition
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0278
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (%)
Estimated Value 139.27
Confidence Interval (2-Sided) 90%
111.01 to 174.73
Estimation Comments [Not Specified]
Time Frame Day 1 to Day 7
Adverse Event Reporting Description

Subjects who entered the study and received at lease one of the treatments under study.

2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16

 
Arm/Group Title RP6530 in Fast Condition RP6530 in Fed Condition
Hide Arm/Group Description

A single dose of RP6530 following fast condition

RP6530: Single oral dose

A single dose of RP6530 following fed condition

RP6530: Single oral dose

All-Cause Mortality
RP6530 in Fast Condition RP6530 in Fed Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
RP6530 in Fast Condition RP6530 in Fed Condition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RP6530 in Fast Condition RP6530 in Fed Condition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/16 (31.25%)      5/16 (31.25%)    
Gastrointestinal disorders     
Abdominal distension  1  1/16 (6.25%)  1 1/16 (6.25%)  1
General disorders     
Fatigue  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Injury, poisoning and procedural complications     
Vessel puncture site bleeding  1  2/16 (12.50%)  2 1/16 (6.25%)  1
vessel puncture site swelling  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Investigations     
Hepatic enzyme increased  1  1/16 (6.25%)  1 2/16 (12.50%)  2
Blood glucose increased  1  0/16 (0.00%)  0 1/16 (6.25%)  1
Protein urine present  1  1/16 (6.25%)  1 0/16 (0.00%)  0
Nervous system disorders     
Dizziness  1  0/16 (0.00%)  0 1/16 (6.25%)  1
Headache  1  1/16 (6.25%)  1 0/16 (0.00%)  0
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Eric Sicard
Organization: Algorithme Pharma Inc.
Phone: (514) 858-6077
EMail: esicard@algopharm.com
Layout table for additonal information
Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02690727    
Other Study ID Numbers: RP6530-1501
ISI-P5-416 ( Other Identifier: Algorithme Pharma Inc. )
First Submitted: February 15, 2016
First Posted: February 24, 2016
Results First Submitted: December 15, 2016
Results First Posted: June 16, 2017
Last Update Posted: November 28, 2017