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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rivipansel

• Registration Number: NCT02998099
• Lead Sponsor: GlycoMimetics Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Study Start: 2017-01
• Primary Completion: 2017-02
• Study Completion: 2017-03
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aged 18-45 years	Rivipansel	A single dose of IV rivipansel over 20 minutes.
Aged 65 and older	Rivipansel	A single dose of IV rivipansel over 20 minutes.

Primary Outcome Measures

Name	Time	Method
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.	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)	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States