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

NCT02636049 | Completed Phase 1 Results

• 1 other identifier: RMFPC-12
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Renal Disease

Keywords

pharmacokinetics; healthy adult volunteer

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics of Triferic Iron Administered IV to Healthy Adults: Maximum Drug Concentration (Cmax) of Total Serum Iron

  Blood samples will be drawn at time = 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 16 hours after the start of Triferic administration on study Day 2 (IV infusion of 6 mg Triferic over 3 hours) and Day 3 (35 microgram/kg IV dose of Triferic given over 30 - 60 seconds) in order to determine the Peak Serum Concentration, corrected (Cmax) of total serum iron.

  16 hours

• Pharmacokinetics of Triferic Iron Administered IV to Healthy Adults: Area Under the Serum Iron Concentration Time Curve From Time Zero to the Time of Last Quantified Concentration (AUC(Last)) of Total Serum Iron

  Blood samples will be drawn at time = 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 16 hours after the start of Triferic administration on study Day 2 (IV infusion of 6 mg Triferic over 3 hours) and study day 3 (35 microgram/kg IV Triferic dose administered in 30 - 60 seconds) in order to determine the AUC(last) of total serum iron.

  16 hours

Secondary Outcomes (2)

• Incidence of Treatment Emergent Adverse Events

  10 - 14 days

• Incidence of Treatment Emergent Serious Adverse Events

  10 - 14 days

Study Arms (2)

Treatment Period: 6 mg Triferic IV over 3 hours

EXPERIMENTAL

Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours on Day 2. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron.

Drug: Triferic

Treatment Period: 35 micrograms/kg IV push

EXPERIMENTAL

Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds on Day 3. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL.

Drug: Triferic

Interventions

Triferic DRUG

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.

Also known as: ferric pyrophosphate citrate, FPC

Treatment Period: 35 micrograms/kg IV push; Treatment Period: 6 mg Triferic IV over 3 hours

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must be able to provide informed consent and have personally signed and dated the study written informed consent document before completing any study-related procedures.
• The subject must be 18-65 years of age inclusive at the time of consent.
• The subject must have a transferrin saturation (TSAT) of 15-50% during Screening.
• The subject must agree to discontinue all iron preparations for 14 days prior to Baseline.
• If the subject is female, she must be premenopausal, non-pregnant and non-lactating, and be at least 90 days post-partum (if applicable) at Screening. Women of childbearing potential must be willing to use appropriate birth control during the entire duration of the study.
• The subject must be willing and able to comply with all study procedures and restrictions.
• The subject must have no clinically-significant abnormal findings on medical history, vital signs, physical examination, or clinical laboratory results during Screening.
• The subject must have a body mass index (BMI) of ≤32.0 kg/m2 at Screening and weigh \>60.0 kg.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

Study Sites (1)

Jasper Clinic

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

ferric pyrophosphate; spleen fibrinolytic proteinase (human)

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Rockwell Medical, Inc

sgrimberg@rockwellmed.com

248-960-9009

Study Officials

• Raymond D Pratt, MD FACP

  Rockwell Medical, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 21, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 20, 2019
• Results First Posted: February 1, 2019

Record last verified: 2019-08

Locations

US (1)