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| Name | Class |
|---|---|
| Algorithme Pharma Inc | INDUSTRY |
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The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.
This is a single-center, open-label, randomized, 4-period crossover study of the pharmacokinetics of a new formulation of deferiprone, delayed release tablets in twenty healthy volunteers. In each study period, blood samples for pharmacokinetics assessment will be collected pre-dose and over 24 hours post-dose. Safety will be assessed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed release, fed conditions | Experimental | A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast |
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| Delayed release, fasting conditions | Experimental | A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast |
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| Delayed release half-tablets | Experimental | A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast |
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| Oral solution, fasting conditions | Active Comparator | A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferiprone delayed release tablet formulation | Drug | Deferiprone 600 mg delayed release tablet formulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose | 24-hour interval |
| Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Time to maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose | 24-hour interval |
| AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide | Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose | 24-hour interval |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events (AEs) | Number of subjects with AEs, by frequency, severity, time to onset, duration, and relatedness to study product. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests. | Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Tricta, MD | ApoPharma Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algorithme Pharma Inc. | Mount Royal | Quebec | H3P 3P1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose | The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest | Posted | Mean | Standard Deviation | μg/mL | 24-hour interval |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delayed Release, Fed Conditions | A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel Puncture Site Haematoma | Injury, poisoning and procedural complications | MedDRA v 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Fradette, PhD | ApoPharma Inc. | 416-401-7543 | cfradett@apopharma.com |
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| ID | Term |
|---|---|
| D000077543 | Deferiprone |
| ID | Term |
|---|---|
| D011728 | Pyridones |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Deferiprone oral solution | Drug | Deferiprone 100 mg/mL oral solution |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast
Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation
| OG002 | Delayed Release Half-tablets | A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation |
| OG003 | Oral Solution, Fasting Conditions | A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast Deferiprone oral solution: Deferiprone 100 mg/mL oral solution |
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| Primary | Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Time to maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose | The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest | Posted | Mean | Standard Deviation | Hour | 24-hour interval |
|
|
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| Primary | AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide | Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose | The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest | Posted | Mean | Standard Deviation | ug*h/mL | 24-hour interval |
|
|
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| Secondary | Number of Subjects With Adverse Events (AEs) | Number of subjects with AEs, by frequency, severity, time to onset, duration, and relatedness to study product. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests. | The safety population included all subjects who received at least one of the investigational products under study. | Posted | Number | participants | Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination) |
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| 0 |
| 18 |
| 3 |
| 18 |
| EG001 | Delayed Release, Fasting Conditions | A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation | 0 | 18 | 4 | 18 |
| EG002 | Delayed Release Half-tablets | A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation | 0 | 19 | 5 | 19 |
| EG003 | Oral Solution, Fasting Conditions | A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast Deferiprone oral solution: Deferiprone 100 mg/mL oral solution | 0 | 17 | 6 | 17 |
| Face Injury | Injury, poisoning and procedural complications | MedDRA v 18.0 | Systematic Assessment |
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| Vessel Puncture Site Bruise | Injury, poisoning and procedural complications | MedDRA v 18.0 | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA v 18.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA v 18.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v 18.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA v 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v 18.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA v 18.0 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA v 18.0 | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA v 18.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA v 18.0 | Systematic Assessment |
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| Lipase Increased | Investigations | MedDRA v 18.0 | Systematic Assessment |
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| Amylase Increased | Investigations | MedDRA v 18.0 | Systematic Assessment |
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| Paresthesia Mucosal | General disorders | MedDRA v 18.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA v 18.0 | Systematic Assessment |
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Sponsor retained title to and the right to publish all documentation, records, raw data, specimens or other work product generated in connection with the trial. Such publications shall not be made without the prior written consent of Sponsor. Neither Party will use the other Party's name in connection with any publication or promotion without the other Party's prior written consent. However, Sponsor has the right to publish appropriate information in order to satisfy regulatory requirements.
| Tmax for serum deferiprone 3-O-glucuronide |
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| AUC0-∞ for serum deferiprone 3-O-glucuronide |
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