Clinical trial NCT02998099: A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel.
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Rivipansel
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
First posted: 2016-12-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: 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.
timeFrame: 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
measure: Clearance (CL)
timeFrame: 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:
measure: Area under the plasma concentration-time profile from time 0 to time of last quantifiable concentration
timeFrame: 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.
measure: Maximum plasma concentration
timeFrame: 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.
measure: Mean elimination half-life
timeFrame: 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.
measure: Volume of distribution at steady state
timeFrame: 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.
measure: Physical examination
timeFrame: Baseline up to 72 hours
measure: Assessment of adverse events
timeFrame: Baseline up to 28 days
measure: Assessment of 12-lead electrocardiogram
timeFrame: Baseline up to 72 hours
measure: Assessment of vital signs
timeFrame: Baseline up to 72 hours
measure: Assessment of laboratory tests
timeFrame: Baseline up to 72 hours
Other outcomes:
measure: Banked Biospecimen
timeFrame: Day 0
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: