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

Phase 1

Completed

• Conditions: Healthy Volunteers; Pharmacokinetics of Vepoloxamer; Renal Impaired
• Interventions: Drug: Vepoloxamer

• Registration Number: NCT02646358
• Lead Sponsor: Mast Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-01
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Primary Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 3: Moderate Renal Impairment	Vepoloxamer	Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours
Cohort 2: Mild Renal Impairment	Vepoloxamer	Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours
Cohort 5: End Stage Renal Disease	Vepoloxamer	Vepoloxamer Injection, 50 mg/kg for 1 hour followed by 15 mg/kg/hr for 5 hours
Cohort 1: Normal Renal Function	Vepoloxamer	Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours
Cohort 4: Severe Renal Impairment	Vepoloxamer	Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics variable - Area under the plasma concentration curve	Time zero through 96 hours

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03	Time zero through Day 14

Trial Locations

Locations (1)

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States