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

Mast Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Renal Impaired; Pharmacokinetics of Vepoloxamer

Treatments: Drug: Vepoloxamer

Study type: Interventional

Funder types: Industry

Identifiers

NCT02646358

MST-188-10

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

27 participants in 5 patient groups

Cohort 1: Normal Renal Function

Experimental group

Description:

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

Treatment:

Drug: Vepoloxamer

Cohort 2: Mild Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Vepoloxamer

Cohort 3: Moderate Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Vepoloxamer

Cohort 4: Severe Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Vepoloxamer

Cohort 5: End Stage Renal Disease

Experimental group

Description:

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

Treatment:

Drug: Vepoloxamer