Phase 1 N=20 Randomized

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02442310 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide — 8.05; 8.21; 7.43; 16.71 μg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Deferiprone delayed release tablet formulation (Drug); Deferiprone oral solution (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: ApoPharma
Primary completion: Jul 2015

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	—

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.

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

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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.