Status:
TERMINATED
Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function
Lead Sponsor:
Mallinckrodt
Conditions:
Renal Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 subj...
Detailed Description
This is a Phase 1 pharmacokinetic study to assess the pharmacokinetics of IK-1001 in healthy volunteers as well as subjects with varying degrees of impaired renal function following a single intraveno...
Eligibility Criteria
Inclusion
- 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
- Body mass index (BMI) within the range of 18 to 40 kg/m2
- Electrocardiogram (ECG) recording without clinically relevant abnormalities
- Having had no febrile or infectious disease for at least seven days prior to dosing of study drug
- 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
- 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)
- All smokers.
- More than moderate alcohol consumption (\>35 g ethanol regularly or \> 2 drinks per day )
- Any history of alcohol or drug abuse
- Any active physical or psychiatric disease, acute or chronic
- Any clinically relevant history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis
- Pregnant or nursing women
- Blood donation within 30 days
- Participation in any clinical study within 30 days prior to the treatment phase of this study
- Lab values outside of reference range and clinically relevant liver function tests (AST, ALT, gamma-GT)
- Positive tests for HIV antibodies, Hepatitis B-virus surface antigen (HBsAg), Anti-Hepatitis C-virus antibodies (Anti-HCV)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00879645
Start Date
August 1 2009
End Date
March 1 2010
Last Update
December 17 2019
Active Locations (1)
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1
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404