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

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

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rivipansel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aged 18-45 years<br>A single dose of IV rivipansel over 20 minutes. | Drug: Rivipansel<br>* A single dose of IV rivipansel over 20 minutes.<br>* Other names: GMI-1070;|
| Experimental: Aged 65 and older<br>A single dose of IV rivipansel over 20 minutes. | Drug: Rivipansel<br>* A single dose of IV rivipansel over 20 minutes.<br>* Other names: GMI-1070;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Rivipansel