NCT02767128

Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers

Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol (Ferrous Sulfate) and Triferic (Ferric Pyrophosphate Citrate) Administered Orally With Shohl's Solution in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Rockwell Medical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.

Detailed description

This is a Phase 1/2, randomized multiple treatments, single dose study assessing the pharmacokinetics (PK) and absolute bioavailability of Fer-In-Sol ( Ferrous Sulfate) and Triferic (ferric pyrophosphate citrate, or FPC) administered orally with Shohl's solution in healthy volunteers. Total participation in the study is approximately six weeks and is comprised of a screening visit, 6 treatment periods, and a follow-up visit. The study will be conducted over a 13 day period: Day 1 will used to determine the baseline serum iron profile for each subject. Each subject will subsequently receive in a randomized sequence between Day 2 and 10: 1. A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw). 2. A single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw 3. a single oral dose of Triferic PO at 3 mg Fe/kg bw 4. a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw. 5. a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw. All subjects will receive a single dose of 6.6 mg Triferic as a 4 hour IV infusion (to mimic the 4 hour iron tolerance test) on Day 12. Blood samples will be obtained at various times to analyze for serum iron parameters and for safety.

Conditions

• Iron-refractory, Iron-deficiency Anemia (IRIDA)

Interventions

Type	Name	Description
DRUG	Triferic
DRUG	Fer-In-Sol
DRUG	Shohl's solution

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-05-10
• Last updated: 2019-02-01
• Results posted: 2019-02-01

Locations

1 site across 1 country: United States