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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Renal Impaired; Pharmacokinetics of Vepoloxamer
• Intervention / Treatment: Drug: Vepoloxamer

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Davita Clinical Research
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Davita Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mast Therapeutics, Inc.
• Investigators: Study Director: Edwin L Parsley, DO, Mast Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: January 1, 2016
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: MST-188-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes