Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function

NCT00879645 | Terminated Phase 1 Results DMC

• 1 other identifier: S103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Renal Impairment

Keywords

Renal Impairment; Renal Disease; Sodium Sulfide

Outcome Measures

Primary Outcomes (3)

• Thiosulfate in Plasma

  Total concentration of thiosulfate in plasma was measured through pharmacokinetic blood sampling.

  8 hours after treatment

• Thiosulfate in Urine

  Total concentration of thiosulfate in urine was measure through pharmacokinetic urine collection

  48 hours after treatment

• Sodium Sulfide in Blood

  Total concentration of sodium sulfide in blood was measured through pharmacokinetic blood sampling.

  8 hours after treatment

Study Arms (4)

Sodium Sulfide - Mild Cohort

EXPERIMENTAL

Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.

Drug: Sodium Sulfide

Sodium Sulfide - Healthy Cohort

EXPERIMENTAL

Healthy subjects received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours

Drug: Sodium Sulfide

Sodium Sulfide - Moderate Cohort

EXPERIMENTAL

Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours

Drug: Sodium Sulfide

Sodium Sulfide - Severe Cohort

EXPERIMENTAL

Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours

Drug: Sodium Sulfide

Interventions

Sodium Sulfide DRUG

Sodium sulfide administered intravenously at 1.5 mg/kg/hr for 3 hours

Also known as: IK-1001

Sodium Sulfide - Mild Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Diseases

Interventions

sodium sulfide

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt

clinicaltrials@mnk.com

800-556-3314

Study Officials

• Brahm Goldstein, MD

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2009
• First Posted: April 10, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 17, 2019
• Results First Posted: November 4, 2010

Record last verified: 2016-10

Locations

US (1)