Conditions: Impaired Renal Function
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 66
Healthy volunteers: yes

Brief summary:
Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias. The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701) following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly subjects and in adult subjects with mild, moderate, severe, and end stage renal disease (ESRD) degrees of impaired renal function. The results of this study will characterize the pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with various degrees of renal impairment, and these data will be compared to healthy adult and elderly subjects.

Detailed description:

Arms:
arm 1: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 arm 2: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 arm 3: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 arm 4: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 arm 5: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 arm 6: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1. Healthy subjects matched to renally impaired subjects in arms 1 through 4. (Note: One healthy subject can match more than one renally impaired subject.)

Interventions: intervention 1: SSP-004184
Intervention descriptions: intervention 1: None

Protocol document: