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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:January 2017
End Date:March 2017

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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)

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


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.
We found this trial at
1
site
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
?
mi
from
Orlando, FL
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