Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mallinckrodt

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)