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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000213246

Enrollment

Registered

2009-04-27

Start date

2009-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

Single dose (6 mg/kg, 10 mg/kg, 16 mg/kg or 32 mg/kg) of FBS0701 administered orally

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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 criteria

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).

Outcome results