Phase 1 N=64 Randomized Quadruple-blind

A Blinded, Placebo-Controlled Study of the Safety and Pharmacokinetics of Single Doses of Intravenous Deferiprone in Healthy Volunteers

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT01989455 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide — 7.406; 17.835; 27.749; 36.644 μg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Deferiprone (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: ApoPharma
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide	7.406; 17.835; 27.749; 36.644; 8.037; 16.490	—
PRIMARY Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide	1.00; 1.00; 1.00; 1.00; 2.50; 2.50	—
PRIMARY Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide	18.326; 41.805; 69.390; 89.250; 38.504; 79.210	—
PRIMARY The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide	1.68; 1.77; 1.83; 1.85; 2.00; 1.94	—
PRIMARY Safety and Tolerability of Single Ascending Doses of Deferiprone When Administered by Intravenous Infusion in Healthy Volunteers.	10; 7; 8; 10; 3	—
SECONDARY Comparison of Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide Between Deferiprone for Infusion and Oral Deferiprone	17.835; 11.692; 16.490; 18.806	—
SECONDARY Absolute Bioavailability of Deferiprone	41.805; 30.796	—
SECONDARY Safety and Tolerability of a Single 1000 mg Oral Dose of Deferiprone	2	—

Summary

Single center, randomized, double-blind, placebo-controlled, adaptive sequential ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of single doses of deferiprone administered by intravenous infusion to healthy males and females. A bioavailability comparison will be included.

Eligibility Criteria

Main Inclusion Criteria:

Healthy adult males or females, at least 18 years old but not older than 50 years.
Body weight at least 60kg.
Body Mass Index (BMI) ≥ 18.50 and ≤ 30.00 kg/m2
Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, ECG, vital signs, physical examination.
Non or ex-smoker (someone who has completely stopped smoking 6 months before study start)
For females, negative result on a serum pregnancy test.

Main Exclusion Criteria:

Absolute neutrophil count (ANC) 220 msec, QRS 119 msec, QTcB > 450 msec for males and >460 msec for females).
Use of acetaminophen, acetylsalicylic acid (ASA), or non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 7 days before study start.
Use of any enzyme-modifying drugs, including strong inhibitors of P450 (CYP) enzymes such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals OR strong inducers of CYP enzymes such as: barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin, and St. John's wart within 28 days prior to study start.
Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse.
Had a clinically significant illness during the 28 days prior to study start.
Receipt of an investigational product in another clinical trial within 28 days prior prior to study start.
Enrolment in a previous cohort of this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01989455). 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.