Phase 1
Completed N=20
Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT02465489 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Cmax for Serum Deferiprone — 3.89; 2.76; 3.02; 13.89 μg/mL
Summary
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone extended release tablets) under fed and fasting conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax for Serum Deferiprone |
3.89; 2.76; 3.02; 13.89; 9.77 | — |
| PRIMARY Tmax for Serum Deferiprone |
3.63; 15.66; 8.29; 0.94; 1.91 | — |
| PRIMARY AUC0-∞for Serum Deferiprone |
31.42; 40.52; 31.72; 34.81; 33.02 | — |
| SECONDARY Number of Subjects With Adverse Events (AEs) |
5; 2; 3; 1; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female aged ≥18 to 220 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
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before Day 1 of this study
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- 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 on HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests
- Positive result on a serum pregnancy test
- Receipt of an investigational product in another clinical trial in the previous 28 days before Day 1 of this study
- Donation of 50 mL or more of blood in the previous 28 days before Day 1 of this study or donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before Day 1 of this study
Data sourced from ClinicalTrials.gov (NCT02465489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.