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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646358
• Other study ID #: MST-188-10
• Status: Completed
• Phase: Phase 1
• First received: January 1, 2016
• Last updated: December 20, 2016
• Start date: January 2016

Study information

• Verified date: December 2016
• Source: Mast Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacokinetics of Vepoloxamer
• Renal Impaired
• Renal Insufficiency

Intervention

Drug:
• Vepoloxamer

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Lakewood	Colorado
United States	DaVita Clinical Research	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mast Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics variable - Area under the plasma concentration curve		Time zero through 96 hours	No
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03		Time zero through Day 14	Yes