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

Healthy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998099
• Other study ID #: B5201004
• Status: Completed
• Phase: Phase 1
• Start date: January 2017
• Est. completion date: March 2017

Study information

• Verified date: June 2020
• Source: GlycoMimetics Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Rivipansel
A single dose of IV rivipansel over 20 minutes.

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlycoMimetics Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Banked Biospecimen		Day 0
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Physical examination		Baseline up to 72 hours
Secondary	Assessment of adverse events		Baseline up to 28 days
Secondary	Assessment of 12-lead electrocardiogram		Baseline up to 72 hours
Secondary	Assessment of vital signs		Baseline up to 72 hours
Secondary	Assessment of laboratory tests		Baseline up to 72 hours