NCT02636049

Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Rockwell Medical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, three-period sequential dosing study being conducted to determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy adults.

Detailed description

This is a Phase 1, open-label, three-period sequential dosing study being conducted primarily to determine the pharmacokinetics of Triferic iron administered intravenously to healthy adults.. Participation will be up to 5 weeks total duration including Screening, Baseline, Treatment Period, and Follow-up. Following Screening, subjects will be admitted to the clinic on Day -1, prior to Baseline (Day 1). During the Treatment Period, subjects will receive two doses of Triferic. Each subject will receive a single 6-mg dose of Triferic administered IV over 3 hours (hr) on one day (Day 2), and a single 35-µg/kg dose of Triferic administered IV push the following day (Day 3). On Day 4, subjects will be discharged from the clinic and will return approximately one week later for their final Follow-up visit.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Triferic	Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-12-21
• Last updated: 2019-08-20
• Results posted: 2019-02-01

Locations

1 site across 1 country: United States