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

NCT ID: NCT02646358

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

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.

Detailed Description

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Conditions

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Pharmacokinetics of Vepoloxamer Healthy Volunteers Renal Impaired

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Cohort 1: Normal Renal Function

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

Group Type EXPERIMENTAL

Vepoloxamer

Intervention Type DRUG

Cohort 2: Mild Renal Impairment

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

Group Type EXPERIMENTAL

Vepoloxamer

Intervention Type DRUG

Cohort 3: Moderate Renal Impairment

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

Group Type EXPERIMENTAL

Vepoloxamer

Intervention Type DRUG

Cohort 4: Severe Renal Impairment

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

Group Type EXPERIMENTAL

Vepoloxamer

Intervention Type DRUG

Cohort 5: End Stage Renal Disease

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

Group Type EXPERIMENTAL

Vepoloxamer

Intervention Type DRUG

Interventions

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Vepoloxamer

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mast Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edwin L Parsley, DO

Role: STUDY_DIRECTOR

Mast Therapeutics, Inc.

Locations

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DaVita Clinical Research

Lakewood, Colorado, United States

Site Status

DaVita Clinical Research

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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MST-188-10

Identifier Type: -

Identifier Source: org_study_id