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Trial record 29 of 46 for:    FERRIC SULFATE

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

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ClinicalTrials.gov Identifier: NCT02767128
Recruitment Status : Completed
First Posted : May 10, 2016
Results First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

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.

Condition or disease Intervention/treatment Phase
Iron-refractory, Iron-deficiency Anemia (IRIDA) Drug: Triferic Drug: Fer-In-Sol Drug: Shohl's solution Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol (Ferrous Sulfate) and Triferic (Ferric Pyrophosphate Citrate) Administered Orally With Shohl's Solution in Healthy Volunteers
Study Start Date : April 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Fer-In-Sol Orally
Patients will receive A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).
Drug: Fer-In-Sol
Other Name: Ferrous Sulfate

Experimental: Shohl's solution followed by Fer-In-Sol Orally
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
Other Name: Ferrous Sulfate

Drug: Shohl's solution
Other Name: Oracit

Experimental: Triferic Orally
Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw.
Drug: Triferic
Other Names:
  • ferric pyrophosphate citrate
  • FPC

Experimental: Shohl's solution followed by Triferic Orally
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
Other Names:
  • ferric pyrophosphate citrate
  • FPC

Drug: Shohl's solution
Other Name: Oracit

Experimental: Shohl's solution followed immediately by Triferic
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
Other Names:
  • ferric pyrophosphate citrate
  • FPC

Drug: Shohl's solution
Other Name: Oracit

Experimental: Triferic via IV
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
Other Names:
  • ferric pyrophosphate citrate
  • FPC

No Intervention: Baseline
baseline serum iron profile will be determined for each patient. no study drug will be administered.



Primary Outcome Measures :
  1. Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax [ Time Frame: 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours ]
    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)


Secondary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 13 days ]
    The number of participants in each treatment group who experienced treatment emergent adverse events will be quantified.

  2. Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: 13 days ]
    The number of participants in each treatment group who experienced treatment emergent serious adverse events will be quantified.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. The patient must have transferrin saturation (TSAT) of ≥20% at Screening.
  4. The patient must have a total iron binding capacity (TIBC) of ≥250 ug/dL at Screening.
  5. 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).
  6. The patient must agree to discontinue all iron preparations for 14 days prior to Baseline.
  7. 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.
  8. The patient must be willing and able to comply with all study procedures and restrictions.
  9. The patient must have no clinically significant abnormal findings on medical history, vital signs, physical examination, or clinical laboratory results during Screening.
  10. The patient must have a body mass index (BMI) of ≤35.0 kg/m2 at Screening.

Exclusion Criteria:

  1. The patient has had administration of oral iron supplements within 14 days prior to Baseline.
  2. The patient has received IV iron within 6 months prior to Screening.
  3. The patient has a serum CRP concentration above the upper limit of normal at Screening or Baseline (> 6.0 mg/L).
  4. 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.
  5. The patient has an acute illness within 14 days prior to Baseline.
  6. 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.
  7. The patient has known or suspected intolerance or hypersensitivity to iron-containing products.
  8. The patient has a history of alcohol or substance abuse within the past year.
  9. The patient has a positive screen for cotinine or drugs of abuse.
  10. The patient is positive for HIV, hepatitis B, or hepatitis C by history.
  11. The patient donated blood or blood products (e.g., plasma or platelets) within 30 days prior to Screening.
  12. The patient has participated in an investigational drug study within 30 days prior to Screening.
  13. The patient is pregnant or intends to become pregnant before completing the study.
  14. The patient's current medical status, in the investigator's opinion, would preclude participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767128


Locations
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United States, Michigan
Jasper Clinic
Kalamazoo, Michigan, United States, 49071
Sponsors and Collaborators
Rockwell Medical Technologies, Inc.
Investigators
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Study Director: Raymond D Pratt, MD, FACP Rockwell Medical, Inc

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Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02767128     History of Changes
Other Study ID Numbers: RMFPC-18
First Posted: May 10, 2016    Key Record Dates
Results First Posted: February 1, 2019
Last Update Posted: February 1, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rockwell Medical Technologies, Inc.:
pharmacokinetics
healthy adult volunteer

Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Citric Acid
Sodium Citrate
Pharmaceutical Solutions
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances