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

NCT02646358 | Completed Phase 1

• 1 other identifier: MST-188-10
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Pharmacokinetics of Vepoloxamer; Healthy Volunteers; Renal Impaired

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics variable - Area under the plasma concentration curve

  Time zero through 96 hours

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03

  Time zero through Day 14

Study Arms (5)

Cohort 1: Normal Renal Function

EXPERIMENTAL

Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours

Drug: Vepoloxamer

Cohort 2: Mild Renal Impairment

EXPERIMENTAL

Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours

Drug: Vepoloxamer

Cohort 3: Moderate Renal Impairment

EXPERIMENTAL

Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours

Drug: Vepoloxamer

Cohort 4: Severe Renal Impairment

EXPERIMENTAL

Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours

Drug: Vepoloxamer

Cohort 5: End Stage Renal Disease

EXPERIMENTAL

Vepoloxamer Injection, 50 mg/kg for 1 hour followed by 15 mg/kg/hr for 5 hours

Drug: Vepoloxamer

Interventions

Vepoloxamer DRUG

Cohort 1: Normal Renal Function; Cohort 2: Mild Renal Impairment; Cohort 3: Moderate Renal Impairment; Cohort 4: Severe Renal Impairment; Cohort 5: End Stage Renal Disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mast Therapeutics, Inc.: lead

Study Sites (2)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Study Officials

• Edwin L Parsley, DO

  Mast Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 1, 2016
• First Posted: January 5, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)