Phase 1
Completed N=20
Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT02442310 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide — 8.05; 8.21; 7.43; 16.71 μg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide |
8.05; 8.21; 7.43; 16.71; 15.77; 19.27 | — |
| PRIMARY Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide |
3.93; 2.05; 3.49; 0.52; 4.63; 3.03 | — |
| PRIMARY AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide |
36.70; 35.77; 37.18; 40.61; 97.52; 100.44 | — |
| SECONDARY Number of Subjects With Adverse Events (AEs) |
3; 4; 5; 6 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT02442310). 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.