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

Completed · Phase 1

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT02636049

Run by

Rockwell Medical Technologies, Inc.

People needed

12

Starts

2015-10-01

Expected to finish

2015-10-01

Last updated by the study team

2019-08-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A subject will not be eligible for inclusion in the study if any of the following criteria apply:
• The subject has a hemoglobin (Hgb) concentration <13.0 g/dL for men or <12 g/dL for women during Screening.
• The subject has a total iron binding capacity (TIBC) <250 µg/dL during Screening.
• The subject has had administration of IV or oral iron supplements (including multivitamins with iron) within 14 days prior to Baseline.
• Subject has concurrent or recurrent disease (e.g., cardiovascular, renal, hepatic, gastrointestinal, malignant, etc.) that could affect the action or disposition of the investigational product utilized in this study, or could affect clinical or laboratory assessments.
• Subject has a C-reactive protein level (CRP) >5 mg/L during Screening, or any rheumatic or autoimmune disease that requires systemic anti-inflammatory or immunomodulatory therapy.
• Subject has an acute illness within 14 days prior to Baseline.
• Subject has known or suspected intolerance or hypersensitivity to iron-containing products.
• Subject has a history of alcohol or substance abuse within the past year.
• Subject has a positive screen for cotinine or drugs of abuse.
• Subject is positive for HIV, hepatitis B, or hepatitis C.
• Subject uses tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch, etc.). Ex-users must report that they have stopped using tobacco for at least 30 days prior to Baseline.
• Subject donated blood or blood products (e.g., plasma or platelets) within 60 days prior to Baseline.
• Subject participated in an investigational drug study within 30 days prior to Baseline.
• Subject is pregnant or intends to become pregnant before completing the study.
• Subject's current medical status, in the investigator's opinion, would preclude participation in the study.

Where it is running

• Jasper Clinic — Kalamazoo, Michigan, United States

Full record on ClinicalTrials.gov

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