CompletedPhase 1ACTRN12609000213246
Safety study of a test oral iron chelator in male iron-overloaded patients
A Dose-Escalation, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FBS0701 in Iron-Overloaded Male Patients
Sponsor
FerroKin BioSciences Inc.
Enrollment
4 participants
Start Date
May 1, 2009
Study Type
Interventional
Conditions
Summary
This aim of this study is to assess the safety of different doses of anovel orally-administered iron chelator in patients with iron-overload.
Eligibility
Sex: MalesMin Age: 18 YearssMax Age: 50 Yearss
Inclusion Criteria1
- Trasnfusion-dependent patients wo have transfusional overload, requiring chronic treatment with deferoxamine, deferasirox or deferiprone. Patients must be willing to discontinue all existing iron chelation therapies for a minimum of seven days prior to admission to clinic.
Exclusion Criteria1
- Received or is anticipated to receive a new prescription systemic or topical medication within 14 days of study start, or over-the-counter medications within 48 hours. Any condition that would interfere with drug absorption (ie chronic diarrhoea).
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Interventions
Single dose (6 mg/kg, 10 mg/kg, 16 mg/kg or 32 mg/kg) of FBS0701 administered orally
Single dose (6 mg/kg, 10 mg/kg, 16 mg/kg or 32 mg/kg) of FBS0701 administered orally
Locations(1)
View Full Details on ANZCTR
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ACTRN12609000213246