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

NCT02767128 | Completed Phase 1 Results

• 1 other identifier: RMFPC-18
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron-refractory, Iron-deficiency Anemia (IRIDA)

Keywords

pharmacokinetics; healthy adult volunteer

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax

  The outcome will be measured by assessing the Cmax of total iron with multiple different oral iron treatment. The following oral iron dosing treatments will be measured: Treatment A (Fer-in-Sol 3 mg iron/kg), Treatment B (Shohl's solution followed after 10 minutes by Fer-In-Sol, 3 mg/kg), Treatment C (Triferic 3 mg iron/kg), Treatment D (Shohl's solution followed after 10 minutes by Triferic 3 mg/kg), Treatment E (Shohl's solution followed immediately by Triferic 3 mg/kg), Treatment F (Triferic 6.6 mg IV over 4 hours)

  0, 1, 2, 4, 6, 8, 12, 16, and 24 hours

Secondary Outcomes (2)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  13 days

• Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

  13 days

Study Arms (7)

Fer-In-Sol Orally

EXPERIMENTAL

Patients will receive A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).

Drug: Fer-In-Sol

Shohl's solution followed by Fer-In-Sol Orally

EXPERIMENTAL

Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw.

Drug: Fer-In-Sol; Drug: Shohl's solution

Triferic Orally

EXPERIMENTAL

Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw.

Drug: Triferic

Shohl's solution followed by Triferic Orally

EXPERIMENTAL

Patients will receive 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.

Drug: Triferic; Drug: Shohl's solution

Shohl's solution followed immediately by Triferic

EXPERIMENTAL

Patients will receive 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.

Drug: Triferic; Drug: Shohl's solution

Triferic via IV

EXPERIMENTAL

Patients will receive IV Triferic iron 6.6 mg diluted in an appropriate amount of D5W administered as a 120 mL infusion intravenously for 4 hours.

Drug: Triferic

Baseline

NO INTERVENTION

baseline serum iron profile will be determined for each patient. no study drug will be administered.

Interventions

Triferic DRUG

Also known as: ferric pyrophosphate citrate, FPC

Shohl's solution followed by Triferic Orally; Shohl's solution followed immediately by Triferic; Triferic Orally; Triferic via IV

Fer-In-Sol DRUG

Also known as: Ferrous Sulfate

Fer-In-Sol Orally; Shohl's solution followed by Fer-In-Sol Orally

Shohl's solution DRUG

Also known as: Oracit

Shohl's solution followed by Fer-In-Sol Orally; Shohl's solution followed by Triferic Orally; Shohl's solution followed immediately by Triferic

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 patient 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 patient has hemoglobin, MCV and reticulocyte values within the reference range for gender. (Male: Hgb ≥13.0 g/dL; Female Hgb ≥ 12.0 g/dL) at Screening.
• The patient must have transferrin saturation (TSAT) of ≥20% at Screening.
• The patient must have a total iron binding capacity (TIBC) of ≥250 ug/dL at Screening.
• The patient must have a serum ferritin within the following reference range for gender at Screening: (Males: 23-336 ng/mL; Females: 11-306 ng/mL).
• The patient must agree to discontinue all iron preparations for 14 days prior to Baseline.
• If the patient is female, she must be 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 patient must be willing and able to comply with all study procedures and restrictions.
• The patient must have no clinically significant abnormal findings on medical history, vital signs, physical examination, or clinical laboratory results during Screening.
• The patient must have a body mass index (BMI) of ≤35.0 kg/m2 at Screening.

You may not qualify if:

• The patient has had administration of oral iron supplements within 14 days prior to Baseline.
• The patient has received IV iron within 6 months prior to Screening.
• The patient has a serum CRP concentration above the upper limit of normal at Screening or Baseline (\> 6.0 mg/L).
• The patient 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.
• The patient has an acute illness within 14 days prior to Baseline.
• The patient is currently using any medication (including prescription, over-the-counter (OTC), herbal, or homeopathic preparations) within 14 days prior to Baseline. Exceptions are contraceptives, hormone replacement therapy, acetaminophen, and non-steroidal anti-inflammatory drugs.
• The patient has known or suspected intolerance or hypersensitivity to iron-containing products.
• The patient has a history of alcohol or substance abuse within the past year.
• The patient has a positive screen for cotinine or drugs of abuse.
• The patient is positive for HIV, hepatitis B, or hepatitis C by history.
• The patient donated blood or blood products (e.g., plasma or platelets) within 30 days prior to Screening.
• The patient has participated in an investigational drug study within 30 days prior to Screening.
• The patient is pregnant or intends to become pregnant before completing the study.
• The patient'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, 49071, United States

Location

MeSH Terms

Conditions

Iron-Refractory Iron Deficiency Anemia

Interventions

ferric pyrophosphate; spleen fibrinolytic proteinase (human); ferrous sulfate; Citrates

Intervention Hierarchy (Ancestors)

Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 10, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 1, 2019
• Results First Posted: February 1, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)