An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment

ApoPharma32 enrolled

Overview

Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg Ferriprox®.

Post-marketing study to evaluate the effect of impaired renal function on the pharmacokinetics (PK) of deferiprone and its 3-O-glucuronide metabolite and on the safety of Ferriprox® in subjects with mild, moderate and severe renal impairment as compared to healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

DeferiproneDRUG

Oral iron chelator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Main Inclusion Criteria: All subjects: 1. Adult males or females, 18 - 75 years of age (inclusive); 2. Body weight ≥ 45 kg; 3. Body mass index (BMI) range of approximately 18.5-32 kg/m\^2 (inclusive); 4. Absolute neutrophil count (ANC) of \>1.5x10\^9/L; Healthy volunteers: 1. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination); 2. eGFR ≥ 90 mL/min/1.73m\^2; Renally impaired subjects: 1. Considered clinically stable in the opinion of the Investigator; 2. Subjects with mild renal impairment (eGFR 60-89 mL/min/1.73m\^E2) OR moderate renal impairment (eGFR 30-59 mL/min/1.73m\^2) OR severe renal impairment (eGFR 15-29 mL/min/1.73m\^2). Main Exclusion Criteria: 1. History of renal transplant; 2. Subjects undergoing any method of dialysis; 3. History or presence of clinically unstable significant respiratory, cardiovascular, pulmonary, hepatic, renal (except for subjects assigned to one of the renally impaired groups), hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease; 4. Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the PK of the investigational medicinal product (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections, acute inflammations, etc.); 5. Clinically significant abnormalities on 12-lead ECG (e.g., QTcF≥430 ms in males or ≥450 ms in females); 6. Evidence of liver damage: hepatitis B and C; aspartate aminotransferase (AST), alanine aminotransferase (ALT) that is considered clinically significant by the Investigator; 7. Participation in another clinical trial within 28 days prior to the study drug administration;

Locations (2)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Algorithme Pharma Inc.

Mount Royal, Quebec, Canada

Outcomes

Primary Outcomes

Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide

Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal, mild, moderate and severe renal impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.

Time frame: 24-hour interval

Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide

Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 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: 24 hour interval

AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide

AUC0-∞ was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.

Time frame: 24 hour interval

T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide

T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.

Time frame: 24 hour interval

Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide

Ae24 (the amount excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.

Data from ClinicalTrials.gov

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An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes