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Trial record 90 of 696 for:    Sickle Cell Disease

Absorption, Metabolism, and Excretion of a Single Dose of Ferriprox® in Patients With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT01835496
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : July 24, 2015
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
ApoPharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Sickle Cell Disease
Intervention Drug: single 1500 mg dose of Ferriprox
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ferriprox
Hide Arm/Group Description A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Ferriprox
Hide Arm/Group Description A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
33.0  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
5
  62.5%
Male
3
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 8 participants
8
1.Primary Outcome
Title Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Hide Description Cmax (maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.
Time Frame 10-hour interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferriprox
Hide Arm/Group Description:
A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: μg/mL
Cmax for serum deferiprone 17.56  (5.76)
Cmax for serum deferiprone 3-O-glucuronide 32.95  (11.85)
2.Primary Outcome
Title Tmax for Deferiprone and Deferiprone 3-O-glucuronide
Hide Description

Tmax (time to the maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 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 10-hour interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferriprox
Hide Arm/Group Description:
A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: hr
Tmax for serum seferiprone
1.000
(0.50 to 2.50)
Tmax for serum deferiprone 3-O-glucuronide
2.750
(1.33 to 3.00)
3.Primary Outcome
Title AUC0-∞ for Serum Deferiprone and Deferiprone 3-O-glucuronide
Hide Description AUC0-∞ (area under the curve, zero to infinity) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.
Time Frame 10-hour interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferriprox
Hide Arm/Group Description:
A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: µg*hr/mL
AUC0-∞ for serum deferiprone 43.37  (5.39)
AUC0-∞ for serum deferiprone 3-O-glucuronide 142.7  (47.02)
4.Primary Outcome
Title T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide
Hide Description T1/2 (apparent terminal elimination half-life) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.
Time Frame 10-hour interval
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferriprox
Hide Arm/Group Description:
A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: hr
T1/2 for serum deferiprone 1.458  (0.207)
T1/2 for serum deferiprone 3-O-glucuronide 1.575  (0.217)
5.Secondary Outcome
Title Frequency of Adverse Events
Hide Description [Not Specified]
Time Frame From Day 1 (Dosing) to Day 7 plus/minus 3 days (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferriprox
Hide Arm/Group Description:
A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
2
6.Secondary Outcome
Title Frequency of Serious Adverse Events
Hide Description [Not Specified]
Time Frame From Day 1 (Dosing) to Day 30 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferriprox
Hide Arm/Group Description:
A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
0
Time Frame From the time of dosing to 7 ±3 days post-dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferriprox
Hide Arm/Group Description A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
All-Cause Mortality
Ferriprox
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ferriprox
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ferriprox
Affected / at Risk (%) # Events
Total   2/8 (25.00%)    
Gastrointestinal disorders   
Abdominal Pain  1  1/8 (12.50%)  1
General disorders   
Fatigue  1  1/8 (12.50%)  1
Fever  1  1/8 (12.50%)  1
Nervous system disorders   
Headache  1  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal Pain  1  1/8 (12.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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.

All unpublished information given to the PI by ApoPharma shall not be published or disclosed to a third party without the prior written consent of ApoPharma.

The data generated by this study are considered confidential information and the property of ApoPharma. This confidential information may be published only in collaboration with participating personnel from ApoPharma or upon ApoPharma written consent to publish the article.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Caroline Fradette, PhD
Organization: ApoPharma Inc.
Phone: 416-401-7543
EMail: cfradett@apopharma.com
Layout table for additonal information
Responsible Party: ApoPharma
ClinicalTrials.gov Identifier: NCT01835496     History of Changes
Other Study ID Numbers: LA41-0412
First Submitted: April 11, 2013
First Posted: April 19, 2013
Results First Submitted: June 26, 2015
Results First Posted: July 24, 2015
Last Update Posted: July 24, 2015