A phase 1 dose-escalation study: safety, tolerability, and pharmacokinetics of FBS0701, a novel oral iron chelator for the treatment of transfusional iron overload.

ABSTRACT:

Background

There is still a clinical need for a well-tolerated and safe iron chelator for the treatment of transfusional iron overload. We describe the pharmacokinetic properties and safety data after 7 days of dosing of FBS0701, a novel oral, once-daily iron chelator.

Design and methods

This phase 1b dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of FBS0701, a novel oral iron chelator for the treatment of transfusional iron overload, was conducted in 16 adult patients with iron overloaded consequent to transfusions. FBS0701 was given daily for 7 days at doses up to 32 mg/kg and was well tolerated at all dose levels.

Results

Pharmacokinetics showed dose-proportionality. The maxium plasma concentration (C(max)) was reach

SUBMITTER: Rienhoff HY 

PROVIDER: S-EPMC3069228 | biostudies-literature | 2011 Apr

REPOSITORIES: biostudies-literature