Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Sodium Sulfide; Sodium Sulfide; Sodium Sulfide; Sodium Sulfide
Intervention description: Sodium sulfide administered intravenously at 1.5 mg/kg/hr for 3 hours; Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours; Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours; Sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Renal Impairment; Renal Disease; Sodium Sulfide

Summary:

      This is a Phase 1 study to assess the pharmacokinetics (PK) of IK-1001 (sodium sulfide) in
      healthy volunteers as well as in subjects with varying degrees of impaired renal function. A
      total of 28 subjects will be enrolled into the study over a 6 month period. There will be 4
      cohorts. The first cohort will consist of subjects with mild renal impairment, the fourth
      cohort will be subjects with intermediate renal impairment and the third cohort will be
      subjects with severe renal impairment and the second cohort will consist of normal healthy
      subjects. All subjects will receive the study drug for 3 hours as a single intravenous (IV)
      infusion and will be followed over a 7 day period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. For normal subjects arm (CrCL > 80 ml/min): Healthy male and female subjects age 18 to
             70 years of age inclusive. Pregnant women are excluded and women of child-bearing
             potential must agree to the use of medically reliable contraceptive methods for the
             duration of the study and for 30 days after study.

             For renally impaired arm: Male and female - pregnant women are excluded and women of
             child-bearing potential must agree to the use of medically reliable contraceptive
             methods for the duration of the study and for 30 days after study. Subjects with mild,
             moderate and severe renal function aged between 18 to 70 years old

          2. Body mass index (BMI) within the range of 18 to 40 kg/m2

          3. Electrocardiogram (ECG) recording without clinically relevant abnormalities

          4. Having had no febrile or infectious disease for at least seven days prior to dosing of
             study drug

          5. Able to communicate well with the study staff and to understand and comply with the
             requirements of the study, understand and sign the written informed consent

        Exclusion Criteria:

          1. High risk patients who may need an urgent dialysis during clinical conduct portion of
             the study (from Day -1 until last PK sampling on Day 7)

          2. All smokers.

          3. More than moderate alcohol consumption (>35 g ethanol regularly or > 2 drinks per day
             )

          4. Any history of alcohol or drug abuse

          5. Any active physical or psychiatric disease, acute or chronic

          6. Any clinically relevant history of drug hypersensitivity, asthma, urticaria or other
             severe allergic diathesis

          7. Pregnant or nursing women

          8. Blood donation within 30 days

          9. Participation in any clinical study within 30 days prior to the treatment phase of
             this study

         10. Lab values outside of reference range and clinically relevant liver function tests
             (AST, ALT, gamma-GT)

         11. Positive tests for HIV antibodies, Hepatitis B-virus surface antigen (HBsAg),
             Anti-Hepatitis C-virus antibodies (Anti-HCV)