Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers

NCT02442310 | Completed Phase 1 Results

• 1 other identifier: LA46-0114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

deferiprone; deferiprone delayed release formulation; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Number of Subjects With Adverse Events (AEs)

  Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination)

Study Arms (4)

Delayed release, fed conditions

EXPERIMENTAL

A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast

Drug: Deferiprone delayed release tablet formulation

Delayed release, fasting conditions

EXPERIMENTAL

A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast

Drug: Deferiprone delayed release tablet formulation

Delayed release half-tablets

EXPERIMENTAL

A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast

Drug: Deferiprone delayed release tablet formulation

Oral solution, fasting conditions

ACTIVE COMPARATOR

A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast

Drug: Deferiprone oral solution

Interventions

Deferiprone delayed release tablet formulation DRUG

Deferiprone 600 mg delayed release tablet formulation

Also known as: Deferiprone

Delayed release half-tablets; Delayed release, fasting conditions; Delayed release, fed conditions

Deferiprone oral solution DRUG

Deferiprone 100 mg/mL oral solution

Also known as: Ferriprox

Oral solution, fasting conditions

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged ≥18 to \<50 years
• A female volunteer of childbearing potential must agree to use an accepted contraceptive regimen from at least 28 days prior to the first administration of the study drug until at least 30 days after the last dose of the study drug
• A sexually active male must agree that he and/or his female partner will use a medically acceptable method of contraception throughout the study and for at least 30 days following drug administration
• Body mass index (BMI) greater than or equal to 18.5 kg/m\^2 and below 30.0 kg/m\^2
• Non- or ex smoker
• Clinical laboratory values within the laboratory's stated normal range; if not within this range, an abnormal value must be without any clinical significance
• Have no clinically significant diseases captured in the medical history, or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, coagulation, ECG, and urinalysis)

You may not qualify if:

• Pregnant or breastfeeding
• Absolute neutrophil count (ANC) \< 1.8 x 109/L at screening (no repeat can be performed)
• History of significant hypersensitivity to deferiprone or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (such as angioedema) to any drugs
• History or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
• Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
• Presence of out-of-range cardiac interval (PR \< 110 msec, PR \> 220 msec, QRS \< 60 msec, QRS \>119 msec and QTcF \> 450 msec for males and \> 460 msec for females) on the screening ECG or other clinically significant ECG abnormalities
• Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
• Any clinically significant illness in the previous 28 days before Day 1 of this study
• Serum ferritin value below the normal limit of the reference laboratory at screening
• Positive urine screening of alcohol and/or drugs of abuse
• Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests

Sponsors & Collaborators

• ApoPharma: lead
• Algorithme Pharma Inc: collaborator

Study Sites (1)

Algorithme Pharma Inc.

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Interventions

Deferiprone

Intervention Hierarchy (Ancestors)

Pyridones; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Caroline Fradette, PhD
• Organization: ApoPharma Inc.

cfradett@apopharma.com

416-401-7543

Study Officials

• Fernando Tricta, MD

  ApoPharma Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 13, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 13, 2016
• Results First Posted: May 13, 2016

Record last verified: 2016-04

Locations

CA (1)