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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02998099

Enrollment

Registered

2016-12-20

Start date

2017-01-31

Completion date

2017-03-31

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteers, Rivipansel

Brief summary

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

Interventions

DRUGRivipansel

A single dose of IV rivipansel over 20 minutes.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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.
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

Secondary

Measure	Time frame
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 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
Assessment of adverse events	Baseline up to 28 days
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.

Other

Measure	Time frame
Banked Biospecimen	Day 0

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026