A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP SINGLE-DOSE STUDY TO ESTIMATE THE EFFECT OF AGE ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF INTRAVENOUS RIVIPANSEL (PF-06460031)

GlycoMimetics Incorporated1 site in 1 country16 target enrollmentJanuary 2017

ConditionsHealthy

InterventionsRivipansel

DrugsRivipansel

Overview

Phase: Phase 1
Intervention: Rivipansel
Conditions: Healthy
Sponsor: GlycoMimetics Incorporated
Enrollment: 16
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

March 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlycoMimetics Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Aged 18-45 years

A single dose of IV rivipansel over 20 minutes.

Intervention: Rivipansel

Aged 65 and older

A single dose of IV rivipansel over 20 minutes.

Intervention: Rivipansel

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)

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 rivipansel.

Secondary Outcomes

Area under the plasma concentration-time profile from time 0 to time of last quantifiable concentration(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 rivipansel.)
Maximum plasma concentration(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 rivipansel.)
Mean elimination half-life(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 rivipansel.)
Volume of distribution at steady state(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 rivipansel.)
Physical examination(Baseline up to 72 hours)
Assessment of adverse events(Baseline up to 28 days)
Assessment of 12-lead electrocardiogram(Baseline up to 72 hours)
Assessment of vital signs(Baseline up to 72 hours)
Assessment of laboratory tests(Baseline up to 72 hours)