A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects

Phase 1CompletedNCT02813798

GlycoMimetics Incorporated28 enrolled

Overview

The purpose of this study is to determine the effect of renal impairment on rivipansel.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Renal Impairment Healthy

Interventions

RivipanselDRUG

A single 840mg dose of Rivipansel over 20 minutes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female subjects of non-childbearing potential or male subjects * Body Mass Index (BMI) of 17.5 to 40.0 kg/m2 * Stable renal function Exclusion Criteria: * A positive urine drug screen for illicit drugs * Treatment with an investigational drug within 30 days of the dose of study medication * Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant * Use of herbal supplements in the 28 days prior to the dose of study medication * Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication * Requiring dialysis

Locations (3)

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Outcomes

Primary Outcomes

Area under the concentration-time curve from time 0 to infinity or area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, as data permit

Time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Clearance (CL)

Time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Renal clearance

Time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Physical examination

Time frame: Baseline up to 96 hours

Assessment of adverse events

Time frame: Baseline up to 28 days

Assessment of 12-lead electrocardiograms

Time frame: Baseline up to 96 hours

Assessment of vital signs

Time frame: Baseline up to 96 hours

Assessment of laboratory tests

Time frame: Baseline up to 96 hours

Secondary Outcomes

Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration

Time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Peak or maximum observed concentration

Data from ClinicalTrials.gov

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