NCT01716455

Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function

A Phase 1, Open-label, Single-dose Study of the Pharmacokinetics, Safety, and Tolerability of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Impaired Renal Function

Interventions

Type	Name	Description
DRUG	SSP-004184

Timeline

• Start date: 2012-10-29
• Primary completion: 2013-03-10
• Completion: 2013-03-10
• First posted: 2012-10-29
• Last updated: 2021-06-10
• Results posted: 2014-02-19

Locations

2 sites across 1 country: United States