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A Blinded, Placebo-Controlled Study of the Safety and Pharmacokinetics of Single Doses of Intravenous Deferiprone in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01989455
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : December 4, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
ApoPharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition Healthy Volunteers
Interventions Drug: Deferiprone
Drug: Placebo
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 500 mg Deferiprone 1000 mg Deferiprone 1500 mg Deferiprone 2000 mg Deferiprone Placebo
Hide Arm/Group Description Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL), followed one week later by a single oral dose of 1000 mg deferiprone oral solution, 80 mg/mL Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of placebo (normal saline solution).
Period Title: Overall Study
Started 14 14 14 14 8
Completed 14 12 13 14 7
Not Completed 0 2 1 0 1
Reason Not Completed
Adverse Event             0             1             0             0             0
Withdrawal by Subject             0             1             0             0             0
Technical problems with infusion             0             0             1             0             1
Arm/Group Title 500 mg Deferiprone for Infusion 1000 mg Deferiprone for Infusion 1500 mg Deferiprone for Infusion 2000 mg Deferiprone for Infusion Placebo Total
Hide Arm/Group Description Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of placebo (normal saline solution). Total of all reporting groups
Overall Number of Baseline Participants 14 14 14 14 8 64
Hide Baseline Analysis Population Description
Healthy volunteers
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 14 participants 14 participants 8 participants 64 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
14
 100.0%
14
 100.0%
14
 100.0%
8
 100.0%
64
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 14 participants 14 participants 8 participants 64 participants
Female
1
   7.1%
4
  28.6%
6
  42.9%
6
  42.9%
4
  50.0%
21
  32.8%
Male
13
  92.9%
10
  71.4%
8
  57.1%
8
  57.1%
4
  50.0%
43
  67.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 14 participants 14 participants 8 participants 64 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   7.1%
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.1%
2
  14.3%
1
   7.1%
3
  21.4%
1
  12.5%
8
  12.5%
White
12
  85.7%
11
  78.6%
13
  92.9%
11
  78.6%
7
  87.5%
54
  84.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
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 14 participants 14 participants 14 participants 14 participants 8 participants 64 participants
14 14 14 14 8 64
1.Primary Outcome
Title Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Hide Description Cmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Time Frame 14-hour interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 500 mg Deferiprone for Infusion 1000 mg Deferiprone for Infusion 1500 mg Deferiprone for Infusion 2000 mg Deferiprone for Infusion
Hide Arm/Group Description:
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Overall Number of Participants Analyzed 14 13 13 14
Mean (Standard Deviation)
Unit of Measure: μg/mL
Cmax for serum deferiprone 7.406  (1.889) 17.835  (2.162) 27.749  (2.768) 36.644  (6.643)
Cmax for serum deferiprone-3-O-glucuronide 8.037  (1.374) 16.490  (4.348) 20.032  (3.757) 30.517  (3.947)
2.Primary Outcome
Title Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Hide Description

Tmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.

The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation).

Time Frame 14-hour interval
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
Arm/Group Title 500 mg Deferiprone for Infusion 1000 mg Deferiprone for Infusion 1500 mg Deferiprone for Infusion 2000 mg Deferiprone for Infusion
Hide Arm/Group Description:
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Overall Number of Participants Analyzed 14 13 13 14
Median (Full Range)
Unit of Measure: hour
Tmax for Serum Deferiprone
1.00
(1.00 to 1.33)
1.00
(0.75 to 1.07)
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Tmax for Serum Deferiprone 3-O-glucuronide
2.50
(1.67 to 3.00)
2.50
(1.67 to 3.00)
2.50
(2.00 to 3.00)
2.50
(1.67 to 3.00)
3.Primary Outcome
Title Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Hide Description AUC0-∞ was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Time Frame 14-hour interval
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
Arm/Group Title 500 mg Deferiprone for Infusion 1000 mg Deferiprone for Infusion 1500 mg Deferiprone for Infusion 2000 mg Deferiprone for Infusion
Hide Arm/Group Description:
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Overall Number of Participants Analyzed 14 13 14 14
Mean (Standard Deviation)
Unit of Measure: μg*h/mL
AUC0-∞ for serum deferiprone 18.326  (4.115) 41.805  (6.797) 69.390  (8.937) 89.250  (17.223)
AUC0-∞ for serum deferiprone 3-O-glucuronide 38.504  (8.011) 79.210  (15.686) 105.829  (13.052) 161.507  (16.876)
4.Primary Outcome
Title The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Hide Description T1/2el was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Time Frame 14-hour interval
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
Arm/Group Title 500 mg Deferiprone for Infusion 1000 mg Deferiprone for Infusion 1500 mg Deferiprone for Infusion 2000 mg Deferiprone for Infusion
Hide Arm/Group Description:
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Overall Number of Participants Analyzed 14 13 13 14
Mean (Standard Deviation)
Unit of Measure: hour
T1/2el for serum deferiprone 1.68  (0.22) 1.77  (0.32) 1.83  (0.22) 1.85  (0.17)
T1/2el for serum deferiprone 3-O-glucuronide 2.00  (0.25) 1.94  (0.25) 2.01  (0.18) 1.94  (0.26)
5.Primary Outcome
Title Safety and Tolerability of Single Ascending Doses of Deferiprone When Administered by Intravenous Infusion in Healthy Volunteers.
Hide Description The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of intravenous deferiprone.
Time Frame From start of intravenous dosing until Day 5 post-dose for all subjects; and from time of oral dose until 24 hours post-dose for subjects who additionally received oral deferiprone
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received study product.
Arm/Group Title 500 mg Deferiprone for Infusion 1000 mg Deferiprone for Infusion 1500 mg Deferiprone for Infusion 2000 mg Deferiprone for Infusion Placebo
Hide Arm/Group Description:
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single intravenous dose of placebo (normal saline solution).
Overall Number of Participants Analyzed 14 14 14 14 8
Measure Type: Number
Unit of Measure: participants
10 7 8 10 3
6.Secondary Outcome
Title Comparison of Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide Between Deferiprone for Infusion and Oral Deferiprone
Hide Description Cmax was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Time Frame 14-hour interval
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
Arm/Group Title 1000 mg Deferiprone for Infusion 1000 mg Oral Deferiprone
Hide Arm/Group Description:
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: μg/mL
Cmax for serum deferiprone 17.835  (2.162) 11.692  (3.436)
Cmax for serum deferiprone-3-O-glucuronide 16.490  (4.348) 18.806  (5.659)
7.Secondary Outcome
Title Absolute Bioavailability of Deferiprone
Hide Description The pharmacokinetic profile was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Time Frame 14-hour interval
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
Arm/Group Title 1000 mg Deferiprone for Infusion 1000 mg Oral Deferiprone
Hide Arm/Group Description:
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: μg*h/mL
41.805  (6.797) 30.796  (7.182)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1000 mg Deferiprone for Infusion, 1000 mg Oral Deferiprone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent ratio
Estimated Value 73.19
Confidence Interval (2-Sided) 90%
68.83 to 77.56
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Safety and Tolerability of a Single 1000 mg Oral Dose of Deferiprone
Hide Description The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of oral deferiprone. Note: All subjects in the 1000 mg cohort received active product, including the 2 who had received placebo for the intravenous infusion.
Time Frame From dosing until 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received study product.
Arm/Group Title 1000 mg Oral Deferiprone
Hide Arm/Group Description:
Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 500 mg Deferiprone for Infusion 1000 mg Deferiprone for Infusion 1500 mg Deferiprone for Infusion 2000 mg Deferiprone for Infusion Placebo 1000 mg Oral Deferiprone
Hide Arm/Group Description Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL) Single intravenous dose of placebo (normal saline solution). Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
All-Cause Mortality
500 mg Deferiprone for Infusion 1000 mg Deferiprone for Infusion 1500 mg Deferiprone for Infusion 2000 mg Deferiprone for Infusion Placebo 1000 mg Oral Deferiprone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
500 mg Deferiprone for Infusion 1000 mg Deferiprone for Infusion 1500 mg Deferiprone for Infusion 2000 mg Deferiprone for Infusion Placebo 1000 mg Oral Deferiprone
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   0/14 (0.00%)      0/14 (0.00%)      0/14 (0.00%)      0/14 (0.00%)      0/8 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
500 mg Deferiprone for Infusion 1000 mg Deferiprone for Infusion 1500 mg Deferiprone for Infusion 2000 mg Deferiprone for Infusion Placebo 1000 mg Oral Deferiprone
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   10/14 (71.43%)      7/14 (50.00%)      8/14 (57.14%)      10/14 (71.43%)      3/8 (37.50%)      2/14 (14.29%)    
Gastrointestinal disorders             
Nausea  1  1/14 (7.14%)  1 1/14 (7.14%)  1 1/14 (7.14%)  1 2/14 (14.29%)  2 0/8 (0.00%)  0 1/14 (7.14%)  1
Vomiting  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/14 (0.00%)  0
Diarrhoea  1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/14 (0.00%)  0
General disorders             
Fatigue  1  2/14 (14.29%)  2 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/8 (0.00%)  0 0/14 (0.00%)  0
Feeling hot  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/8 (0.00%)  0 0/14 (0.00%)  0
Feeling of body temperature change  1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/14 (0.00%)  0
Injury, poisoning and procedural complications             
Catheter site swelling  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/14 (0.00%)  0
Procedural complication  1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/14 (0.00%)  0
Procedural dizziness  1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/14 (0.00%)  0
Vessel puncture site pain  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/14 (0.00%)  0
Vessel puncture site reaction  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/8 (0.00%)  0 0/14 (0.00%)  0
Catheter site pain  1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/14 (0.00%)  0
Investigations             
C-reactive protein increased  1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/14 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite  1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/8 (0.00%)  0 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders             
Back pain  1  2/14 (14.29%)  2 1/14 (7.14%)  1 1/14 (7.14%)  1 1/14 (7.14%)  1 0/8 (0.00%)  0 0/14 (0.00%)  0
Nervous system disorders             
Somnolence  1  8/14 (57.14%)  9 5/14 (35.71%)  5 4/14 (28.57%)  4 5/14 (35.71%)  5 0/8 (0.00%)  0 1/14 (7.14%)  1
Headache  1  4/14 (28.57%)  4 4/14 (28.57%)  4 3/14 (21.43%)  3 4/14 (28.57%)  5 0/8 (0.00%)  0 1/14 (7.14%)  1
Dizziness  2  1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/14 (0.00%)  0
Head discomfort  2  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/14 (0.00%)  0
Hypoaesthesia  2  1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/8 (0.00%)  0 0/14 (0.00%)  0
Vertigo  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 0/8 (0.00%)  0 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Dysphonia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/14 (0.00%)  0
Sneezing  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/8 (0.00%)  0 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders             
Erythema  1  0/14 (0.00%)  0 0/14 (0.00%)  0 2/14 (14.29%)  2 0/14 (0.00%)  0 0/8 (0.00%)  0 0/14 (0.00%)  0
Generalized erythema  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/8 (0.00%)  0 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v 16.1
2
Term from vocabulary, MedDRA 16.1
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
Name/Title: Caroline Fradette, PhD
Organization: ApoPharma Inc.
Phone: 416-401-7543
Responsible Party: ApoPharma
ClinicalTrials.gov Identifier: NCT01989455     History of Changes
Other Study ID Numbers: LA42-0113
First Submitted: November 15, 2013
First Posted: November 21, 2013
Results First Submitted: November 28, 2014
Results First Posted: December 4, 2014
Last Update Posted: December 23, 2014