A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel.

Phase 1CompletedNCT02998099

GlycoMimetics Incorporated16 enrolled

Overview

The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of IV rivipansel.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

RivipanselDRUG

A single dose of IV rivipansel over 20 minutes.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy female subjects of non-childbearing potential or healthy male subjects who are between the ages of 18-45 years or 65 years of age or older. * Body mass index (BMI) of 17.5 to 40 kg/m2 Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * Pregnant females; breastfeeding female subjects; male subjects with partners currently pregnant * Treatment with another investigational drug within 30 days or 5 half-lives preceding the dose of study medication * Blood donation within 60 days prior to dosing.

Locations (1)

Orlando Clinical Research Center

Orlando, Florida, United States

Outcomes

Primary Outcomes

Area under the plasma concentration-time profile from time 0 extrapolated to infinite time or area under the plasma concentration-time from time 0 to 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 and 72 hours following single dose administration of IV rivipansel

Clearance (CL)