A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
Condition: Kidney Failure, Chronic Therapy; Hemodialysis
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Intervention: soluble ferric pyrophosphate; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Soluble Ferric Pyrophosphate, Pharmacokinetics, Iron, Hemodialysis

Summary:

      The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of
      intravenously administered Soluble Ferric Pyrophosphate
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-55 inclusive at the time of consent. This inclusion criterion will only be
             assessed at the first screening visit.

          2. Male or non-pregnant, non-lactating female who is at least 90 days post-partum.

          3. Subject is willing to comply with any applicable contraceptive requirements of the
             protocol.

          4. Satisfactory medical assessment with no clinically significant or relevant
             abnormalities in medical history, physical examination (PE), vital signs,
             electrocardiogram (ECG) and laboratory evaluation (hematology, biochemistry,
             urinalysis) as assessed by the Investigator.

          5. An understanding, ability and willingness to fully comply with study procedures and
             restrictions.

          6. Ability to provide written, personally signed and dated informed consent to
             participate in the study, in accordance with the International Conference on
             Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable
             regulations, before completing any study-related procedures.

          7. Body Mass Index (BMI) between 20.0 and 32.0 kg/m² inclusive. This inclusion criterion
             will only be assessed at the first screening visit.

          8. Subjects must agree to discontinue all iron preparations for 14 days prior to study
             drug administration.

        Exclusion Criteria:

          1. Current or recurrent disease (e.g. cardiovascular, renal, liver, gastro-intestinal,
             malignancy or other conditions) that could affect the action, absorption or
             disposition of the investigational product utilized in this study, or could affect
             clinical or laboratory assessments.

          2. Hemoglobin < 11 g/dL or Hematocrit < 30%.

          3. Serum iron concentration ≤ 70 µg/dL (male or female).

          4. Current or relevant previous history of physical or psychiatric illness, any medical
             disorder that may require treatment or make the subject unlikely to fully complete the
             study, or any condition that presents undue risk from the investigational product or
             study procedures.

          5. Significant illness, as judged by the investigator, within 2 weeks of the first dose
             of investigational product.

          6. Current use of any medication (including prescription, over the counter [OTC], herbal
             or homeopathic preparations) within 14 days of first dose of investigational product.
             Exceptions are hormonal replacement therapy, hormonal contraceptives, acetaminophen
             and non-steroidal anti-inflammatory drugs.

          7. Known or suspected intolerance or hypersensitivity to iron containing product(s).

          8. History of alcohol or other substance abuse within the last year.

          9. A positive screen for cotinine, alcohol or drugs of abuse.

         10. Male subjects who consume more than 21 units of alcohol per week or three units per
             day. Female subjects who consume more than 14 units of alcohol per week or two units
             per day. 1 alcohol unit =1 beer = 1 wine (5oz) = 1 liquor (1.5 oz.).

         11. A history of a positive human immunodeficiency virus (HIV) antibody screen, Hepatitis
             B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibody screen.

         12. Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing
             products in any form (e.g. gum, patch). Ex-users must report that they have stopped
             using tobacco for at least 30 days prior to receiving the first dose of
             investigational product.

         13. Routine consumption of more than five units of caffeine per day or subjects who
             experience caffeine withdrawal headaches. One caffeine unit is contained in the
             following items: one 6-oz. cup of coffee, two 12-oz. cans of cola, one 12-oz. cup of
             tea, three 1-oz. chocolate bars.

         14. Donation of blood or blood products (e.g., plasma or platelets) within 60 days prior
             to receiving the first dose of investigational product.

         15. Use of another investigational product within 30 days prior to receiving the first
             dose of investigational product or active enrolment in another drug or vaccine
             clinical study.

         16. Pregnancy or intention to become pregnant before completing all study drug treatment.

         17. Current medical status that, in the investigators opinion, would preclude
             participation in the study.