Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Triferic
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetics; healthy adult volunteer

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.
    

Eligibility criteria:

        Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for
        inclusion in the study:

          1. 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.

          2. The subject must be 18-65 years of age inclusive at the time of consent.

          3. The subject must have a transferrin saturation (TSAT) of 15-50% during Screening.

          4. The subject must agree to discontinue all iron preparations for 14 days prior to
             Baseline.

          5. 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.

          6. The subject must be willing and able to comply with all study procedures and
             restrictions.

          7. The subject must have no clinically-significant abnormal findings on medical history,
             vital signs, physical examination, or clinical laboratory results during Screening.

          8. The subject must have a body mass index (BMI) of ≤32.0 kg/m2 at Screening and weigh
             >60.0 kg.

        Exclusion Criteria:

        A subject will not be eligible for inclusion in the study if any of the following criteria
        apply:

          1. The subject has a hemoglobin (Hgb) concentration <13.0 g/dL for men or <12 g/dL for
             women during Screening.

          2. The subject has a total iron binding capacity (TIBC) <250 µg/dL during Screening.

          3. The subject has had administration of IV or oral iron supplements (including
             multivitamins with iron) within 14 days prior to Baseline.

          4. 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.

          5. 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.

          6. Subject has an acute illness within 14 days prior to Baseline.

          7. Subject has known or suspected intolerance or hypersensitivity to iron-containing
             products.

          8. Subject has a history of alcohol or substance abuse within the past year.

          9. Subject has a positive screen for cotinine or drugs of abuse.

         10. Subject is positive for HIV, hepatitis B, or hepatitis C.

         11. 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.

         12. Subject donated blood or blood products (e.g., plasma or platelets) within 60 days
             prior to Baseline.

         13. Subject participated in an investigational drug study within 30 days prior to
             Baseline.

         14. Subject is pregnant or intends to become pregnant before completing the study.

         15. Subject's current medical status, in the investigator's opinion, would preclude
             participation in the study.