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Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals

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ClinicalTrials.gov Identifier: NCT02958982
Recruitment Status : Terminated (Significant recruitment delay in POC part)
First Posted : November 8, 2016
Results First Posted : October 4, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Healthy Volunteers
Asthma
Interventions Drug: RP3128
Drug: Placebo
Enrollment 57
Recruitment Details Participants were recruited between 03 Nov 2016 to 05 Apr 2017 for Single Ascending Dose (SAD) study and patients were recruited between 12 May 2017 to 26 Aug 2017 for Multiple Ascending Dose (MAD) study
Pre-assignment Details There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo (SAD and MAD). The proof of concept study was terminated prematurely after enrolling only one patient. Therefore, no analysis was performed.
Arm/Group Title Pooled Placebo (SAD) RP3128_25 mg_SAD RP3128_50 mg_SAD RP3128_100 mg_SAD RP3128_200 mg_SAD RP3128_400 mg_SAD Pooled Placebo (MAD) RP3128_25 mg_MAD RP3128_100 mg_MAD RP3128_400 mg_MAD Proof of Concept
Hide Arm/Group Description

Placebo

Placebo: Participants will receive single oral dose of RP3128 in SAD,

Participants will receive single oral dose of 25 mg of RP3128 once a day in SAD Participants will receive single oral dose of 50 mg of RP3128 once a day in SAD Participants will receive single oral dose of 100 mg of RP3128 once a day in SAD Participants will receive single oral dose of 200 mg of RP3128 once a day in SAD Participants will receive single oral dose of 400 mg of RP3128 once a day in SAD

Placebo

Placebo: Participants will receive single oral dose of RP3128 in MAD,

Participants will receive multiple oral dose of 25 mg of RP3128 for a week in MAD, Participants will receive multiple oral dose of 100 mg of RP3128 for a week in MAD, Participants will receive multiple oral dose of 400 mg of RP3128 for a week in MAD, RP3128/Placebo
Period Title: Cohort 1: 25 mg in SAD Study
Started 1 3 0 0 0 0 0 0 0 0 0
Completed 1 3 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Cohort 2: 50 mg in SAD Study
Started 2 0 4 0 0 0 0 0 0 0 0
Completed 2 0 4 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Cohort 3: 100 mg in SAD Study
Started 2 0 0 4 0 0 0 0 0 0 0
Completed 2 0 0 4 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Cohort 4: 200 mg in SAD Study
Started 2 0 0 0 6 0 0 0 0 0 0
Completed 2 0 0 0 6 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Cohort 5: 400 mg in SAD Study
Started 2 0 0 0 0 6 0 0 0 0 0
Completed 2 0 0 0 0 6 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Cohort 1 : 25 mg in MAD Study
Started 0 0 0 0 0 0 2 6 0 0 0
Completed 0 0 0 0 0 0 2 6 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Cohort 2: 100 mg in MAD Study
Started 0 0 0 0 0 0 2 0 6 0 0
Completed 0 0 0 0 0 0 2 0 6 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Cohort 3: 400 mg in MAD Study
Started 0 0 0 0 0 0 2 0 0 6 0
Completed 0 0 0 0 0 0 2 0 0 6 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Period Title: Proof of Concept Study
Started 0 0 0 0 0 0 0 0 0 0 1
Completed 0 0 0 0 0 0 0 0 0 0 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Pooled Placebo (SAD) RP3128_25 mg_SAD RP3128_50 mg_SAD RP3128_100 mg_SAD RP3128_200 mg_SAD RP3128_400 mg_SAD Pooled Placebo RP3128_25 mg_MAD RP3128_100 mg_MAD RP3128_400 mg_MAD Proof of Concept Total
Hide Arm/Group Description Placebo: Participants will receive single oral dose of Placebo in SAD RP3128: Participants will receive single oral dose of 25 mg of RP3128 in SAD RP3128: Participants will receive single oral dose of 50 mg of RP3128 in SAD RP3128: Participants will receive single oral dose of 100 mg of RP3128 in SAD RP3128: Participants will receive single oral dose of 200 mg of RP3128 in SAD RP3128: Participants will receive single oral dose of 400 mg of RP3128 in SAD Placebo: Participants will receive multiple oral doses of placebo in MAD RP3128: Participants will receive multiple oral dose of 25 mg of RP3128 in MAD RP3128: Participants will receive multiple oral dose of 100 mg of RP3128 in MAD RP3128: Participants will receive multiple oral dose of 400 mg of RP3128 in MAD Patient received at least one dose of RP3128/placebo Total of all reporting groups
Overall Number of Baseline Participants 9 3 4 4 6 6 6 6 6 6 1 57
Hide Baseline Analysis Population Description
Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD. Since the POC study terminated, one patient who recruited in POC was not considered for baseline measures
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 4 participants 4 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 1 participants 57 participants
<=18 years
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
Between 18 and 65 years
8
  88.9%
3
 100.0%
4
 100.0%
4
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
1
 100.0%
56
  98.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 3 participants 4 participants 4 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 1 participants 57 participants
29.4  (8.26) 36.3  (4.93) 36.3  (9.07) 31.5  (6.61) 38.2  (8.30) 34.7  (9.42) 36.7  (4.59) 29.5  (6.92) 33.2  (3.43) 36.5  (5.39) 32.0  (0) 33.6  (7.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 4 participants 4 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 1 participants 57 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
9
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
1
 100.0%
57
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 4 participants 4 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 1 participants 57 participants
Hispanic or Latino
2
  22.2%
3
 100.0%
1
  25.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
3
  50.0%
3
  50.0%
2
  33.3%
0
   0.0%
16
  28.1%
Not Hispanic or Latino
7
  77.8%
0
   0.0%
3
  75.0%
4
 100.0%
5
  83.3%
6
 100.0%
5
  83.3%
3
  50.0%
3
  50.0%
4
  66.7%
1
 100.0%
41
  71.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 4 participants 4 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 1 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
Asian
0
   0.0%
1
  33.3%
1
  25.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
  16.7%
1
 100.0%
6
  10.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  22.2%
0
   0.0%
1
  25.0%
0
   0.0%
2
  33.3%
4
  66.7%
2
  33.3%
1
  16.7%
2
  33.3%
1
  16.7%
0
   0.0%
15
  26.3%
White
6
  66.7%
2
  66.7%
2
  50.0%
3
  75.0%
3
  50.0%
2
  33.3%
3
  50.0%
5
  83.3%
3
  50.0%
4
  66.7%
0
   0.0%
33
  57.9%
More than one race
1
  11.1%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 9 participants 3 participants 4 participants 4 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 1 participants 57 participants
9 3 4 4 6 6 6 6 6 6 1 57
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame Baseline through 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD.
Arm/Group Title Pooled Placebo (SAD) RP3128_25 mg_SAD RP3128_50 mg_SAD RP3128_100 mg_SAD RP3128_200 mg_SAD RP3128_400 mg_SAD Pooled Placebo (MAD) RP3128_25 mg_MAD RP3128_100 mg_MAD RP3128_400 mg_MAD Proof of Concept
Hide Arm/Group Description:
Placebo: Participants will receive single oral dose of RP3128 in SAD,
RP3128: Participants will receive single oral dose of 25 mg of RP3128 in SAD
RP3128: Participants will receive single oral dose of 50 mg of RP3128 in SAD
RP3128: Participants will receive single oral dose of 100 mg of RP3128 in SAD
RP3128: Participants will receive single oral dose of 200 mg of RP3128 in SAD
RP3128: Participants will receive single oral dose of 400 mg of RP3128 in SAD
Placebo: Participants will receive single oral dose of RP3128 in MAD,
RP3128 (MAD): Participants will receive multiple oral dose of 25 mg of RP3128 in MAD,
RP3128 (MAD): Participants will receive multiple oral dose of 100 mg of RP3128 in MAD study
RP3128 (MAD): Participants will receive multiple oral dose of 400 mg of RP3128 in MAD study
Patient received at least one dose of RP3128/Placebo
Overall Number of Participants Analyzed 9 3 4 4 6 6 6 6 6 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
4
  44.4%
1
  33.3%
2
  50.0%
4
 100.0%
2
  33.3%
4
  66.7%
3
  50.0%
1
  16.7%
0
   0.0%
2
  33.3%
0
   0.0%
2.Secondary Outcome
Title Peak Plasma Concentration (Cmax)
Hide Description Cmax after administration of RP3128/ placebo in part 1 and part 2
Time Frame Pre-dose through 48 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pooled Placebo (SAD) RP3128_25 mg_SAD RP3128_50 mg_SAD RP3128_100 mg_SAD RP3128_200 mg_SAD RP3128_400 mg_SAD Pooled Placebo (MAD) RP3128_25 mg_MAD RP3128_100 mg_MAD RP3128_400 mg_MAD Proof of Concept
Hide Arm/Group Description:
Placebo: Participants will receive single oral dose of RP3128 in SAD,
RP3128: Participants will receive single oral dose of 25 mg RP3128 in SAD (Day1)
RP3128: Participants will receive single oral dose of 50 mg RP3128 in SAD (Day1)
RP3128: Participants will receive single oral dose of 100 mg RP3128 in SAD (Day1)
RP3128: Participants will receive single oral dose of 200 mg RP3128 in SAD (Day1)
RP3128: Participants will receive single oral dose of 400 mg RP3128 in SAD (Day1)
Placebo: Participants will receive single oral dose of RP3128 in MAD,
RP3128 (MAD): Participants will receive multiple oral dose of 25 mg of RP3128 in MAD (Day 7),
RP3128 (MAD): Participants will receive multiple oral dose of 100 mg of RP3128 in MAD (Day 7),
RP3128 (MAD): Participants will receive multiple oral dose of 400 mg of RP3128 in MAD (Day 7),
Participants will RP3128/Placebo
Overall Number of Participants Analyzed 9 3 4 4 6 6 6 6 6 6 1
Mean (Standard Deviation)
Unit of Measure: micrograms/mL
0  (0) 0.171  (0.041) 0.305  (0.075) 0.561  (0.12) 0.64  (0.29) 0.915  (0.41) 0  (0) 0.533  (0.10) 2.034  (1.11) 3.95  (2.16) 0  (0)
3.Secondary Outcome
Title Measurement of Cytokines
Hide Description Levels of cytokines following LPS (lipopolysaccharide) or CD3/CD28 stimulation.
Time Frame Predose and Day 7 in Part 2
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Fractional Exhaled Nitric Oxide (FeNo)
Hide Description Change in FeNo after administration of RP3128/ placebo in part 3
Time Frame Prechallenge to 3, 8 and 24 hours post challenge in Part 3
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Area Under Effective Concentration (AUEC)
Hide Description AUEC0-3h, AUEC3-8h after administration of RP3128/ placebo in part 3
Time Frame 0 to 3 hours and 3 to 8 hours post allergen challenge in Part 3
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Cell Count
Hide Description Absolute and % counts of sputum eosinophils and neutrophils
Time Frame 8 and 24 hours post allergen challenge in Part 3
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Area Under the Plasma-Concentration
Hide Description AUC0-t after administration of RP3128/ placebo in part 1 and part 2
Time Frame Pre-dose through 48 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pooled Placebo (SAD) RP3128_25 mg_SAD RP3128_50 mg_SAD RP3128_100 mg_SAD RP3128_200 mg_SAD RP3128_400 mg_SAD Pooled Placebo (MAD) RP3128_25 mg_MAD RP3128_100 mg_MAD RP3128_400 mg_MAD Proof of Concept
Hide Arm/Group Description:
Placebo: Participants will receive single oral dose of RP3128 in SAD,
RP3128: Participants will receive single oral dose of 25 mg RP3128 in SAD (Day1)
RP3128: Participants will receive single oral dose of 50 mg RP3128 in SAD (Day1)
RP3128: Participants will receive single oral dose of 100 mg RP3128 in SAD (Day1)
RP3128: Participants will receive single oral dose of 200 mg RP3128 in SAD (Day1)
RP3128: Participants will receive single oral dose of 400 mg RP3128 in SAD (Day1)
Placebo: Participants will receive single oral dose of RP3128 in MAD,
RP3128 (MAD): Participants will receive multiple oral dose of 25 mg of RP3128 in MAD (Day 7),
RP3128 (MAD): Participants will receive multiple oral dose of 100 mg of RP3128 in MAD (Day 7),
RP3128 (MAD): Participants will receive multiple oral dose of 400 mg of RP3128 in MAD (Day 7),
Participants will RP3128/Placebo
Overall Number of Participants Analyzed 9 3 4 4 6 6 6 6 6 6 1
Mean (Standard Deviation)
Unit of Measure: micrograms*hours/mL
0  (0) 8.821  (0.47) 10.766  (3.884) 30.340  (9.968) 37.011  (14.56) 94.227  (39.29) 0  (0) 7.934  (1.23) 31.034  (19.71) 61.821  (39.023) 0  (0)
Time Frame 15 Days
Adverse Event Reporting Description There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
 
Arm/Group Title Pooled Placebo (SAD) RP3128_25 mg_SAD RP3128_50 mg_SAD RP3128_100 mg_SAD RP3128_200 mg_SAD RP3128_400 mg_SAD Pooled Placebo (MAD) RP3128_25 mg_MAD RP3128_100 mg_MAD RP3128_400 mg_MAD Proof of Concept
Hide Arm/Group Description Placebo: Participants will receive single oral dose of RP3128 in SAD, RP3128: Participants will receive single oral dose 25 mg of RP3128 in SAD RP3128: Participants will receive single oral dose 50 mg of RP3128 in SAD RP3128: Participants will receive single oral dose 100 mg of RP3128 in SAD RP3128: Participants will receive single oral dose 200 mg of RP3128 in SAD RP3128: Participants will receive single oral dose 400 mg of RP3128 in SAD Placebo: Participants will receive single oral dose of RP3128 in MAD, RP3128 (MAD): Participants will receive multiple oral dose 25 mg of RP3128 for one week in MAD, RP3128 (MAD): Participants will receive multiple oral dose 100 mg of RP3128 for one week in MAD, RP3128 (MAD): Participants will receive multiple oral dose 400 mg of RP3128 for one week in MAD, Participants will receive RP3128/Placebo
All-Cause Mortality
Pooled Placebo (SAD) RP3128_25 mg_SAD RP3128_50 mg_SAD RP3128_100 mg_SAD RP3128_200 mg_SAD RP3128_400 mg_SAD Pooled Placebo (MAD) RP3128_25 mg_MAD RP3128_100 mg_MAD RP3128_400 mg_MAD Proof of Concept
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/3 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/1 (0.00%)    
Hide Serious Adverse Events
Pooled Placebo (SAD) RP3128_25 mg_SAD RP3128_50 mg_SAD RP3128_100 mg_SAD RP3128_200 mg_SAD RP3128_400 mg_SAD Pooled Placebo (MAD) RP3128_25 mg_MAD RP3128_100 mg_MAD RP3128_400 mg_MAD Proof of Concept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/3 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pooled Placebo (SAD) RP3128_25 mg_SAD RP3128_50 mg_SAD RP3128_100 mg_SAD RP3128_200 mg_SAD RP3128_400 mg_SAD Pooled Placebo (MAD) RP3128_25 mg_MAD RP3128_100 mg_MAD RP3128_400 mg_MAD Proof of Concept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      1/3 (33.33%)      2/4 (50.00%)      4/4 (100.00%)      2/6 (33.33%)      4/6 (66.67%)      3/6 (50.00%)      1/6 (16.67%)      0/6 (0.00%)      2/6 (33.33%)      0/1 (0.00%)    
Eye disorders                       
Eye Disorders   0/9 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders                       
Gastrointestinal disorders   1/9 (11.11%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
General disorders                       
General disorders   0/9 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  5 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations                       
Infections and infestations   1/9 (11.11%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
Injury, poisoning and procedural complications                       
Injury, poisoning and procedural complications   0/9 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
Investigations                       
Investigations   2/9 (22.22%)  3 1/3 (33.33%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  4 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
Metabolism and nutrition disorders                       
Metabolism and nutrition disorders   0/9 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders                       
Musculoskeletal and connective tissue disorders   2/9 (22.22%)  3 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders                       
Nervous system disorders   1/9 (11.11%)  3 0/3 (0.00%)  0 1/4 (25.00%)  1 2/4 (50.00%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/1 (0.00%)  0
Psychiatric disorders                       
Psychiatric disorders   0/9 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
Renal and urinary disorders                       
Renal and urinary disorders   1/9 (11.11%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Respiratory, thoracic and mediastinal disorders   1/9 (11.11%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 2/4 (50.00%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0
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. Prajak Barde
Organization: Rhizen Pharmaceuticals S.A.
Phone: +41 32 580 0113
EMail: pjb@rhizen.com
Layout table for additonal information
Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02958982    
Other Study ID Numbers: RP3128-1601
First Submitted: October 31, 2016
First Posted: November 8, 2016
Results First Submitted: December 27, 2018
Results First Posted: October 4, 2019
Last Update Posted: October 4, 2019