Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer

Study Overview
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Brief Summary
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This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.

Official Title
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A Phase 1, Open-Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Vepoloxamer in Subjects With Varying Degrees of Renal Impairment and Healthy Matched Control Subjects With Normal Renal Function

Conditions
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Pharmacokinetics of Vepoloxamer, Healthy Volunteers, Renal Impaired

Intervention / Treatment
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* Drug: Vepoloxamer


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2 Subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days If female, subject must not be pregnant or lactating, have a negative pregnancy test, and agrees to sexual abstinence, or use of an appropriate birth control method from screening through 30 days after study drug administration If male, subject agrees to sexual abstinence, is surgically sterile, or is using an appropriate birth control method from screening through 30 days after study drug administration Considered by the Investigator to be healthy or clinically stable with respect to underlying renal impairment based on medical evaluation including vital signs, ECG and laboratory test results Non-smoker, or smokes fewer than 10 cigarettes/day Key Exclusion Criteria Uncontrolled medical condition (treated or untreated) considered to be clinically significant by the Investigator Experienced an illness considered by the Investigator to be clinically significant within 2 weeks of study drug administration Treatment with another investigational drug or device study within 30 days or 5 half-lives (whichever is longer) prior to screening Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1 Donated or lost a significant volume of blood or plasma within 90 days prior to study drug administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Normal Renal Function<br>Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours | Drug: Vepoloxamer<br> <br> |
| Experimental: Cohort 2: Mild Renal Impairment<br>Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours | Drug: Vepoloxamer<br> <br> |
| Experimental: Cohort 3: Moderate Renal Impairment<br>Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours | Drug: Vepoloxamer<br> <br> |
| Experimental: Cohort 4: Severe Renal Impairment<br>Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours | Drug: Vepoloxamer<br> <br> |
| Experimental: Cohort 5: End Stage Renal Disease<br>Vepoloxamer Injection, 50 mg/kg for 1 hour followed by 15 mg/kg/hr for 5 hours | Drug: Vepoloxamer<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics variable - Area under the plasma concentration curve |  | Time zero through 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03 |  | Time zero through Day 14 |