A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of renal impairment on rivipansel.

Official Title
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A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE DOSE STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF RIVIPANSEL (PF-06460031) IN SUBJECTS WITH RENAL IMPAIRMENT AND IN HEALTHY SUBJECTS

Conditions
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Renal Impairment, Healthy

Intervention / Treatment
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* Drug: Rivipansel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects of non-childbearing potential or male subjects Body Mass Index (BMI) of 17.5 to 40.0 kg/m2 Stable renal function Exclusion Criteria: A positive urine drug screen for illicit drugs Treatment with an investigational drug within 30 days of the dose of study medication Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant Use of herbal supplements in the 28 days prior to the dose of study medication Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication Requiring dialysis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Mild Renal Impairment<br>A single dose of IV Rivipansel over 20 minutes | Drug: Rivipansel<br>* A single 840mg dose of Rivipansel over 20 minutes<br>* Other names: GMI-1070;|
| Experimental: Moderate Renal Impairment<br>A single dose of IV Rivipansel over 20 minutes | Drug: Rivipansel<br>* A single 840mg dose of Rivipansel over 20 minutes<br>* Other names: GMI-1070;|
| Experimental: Severe Renal Impairment<br>A single dose of IV Rivipansel over 20 minutes | Drug: Rivipansel<br>* A single 840mg dose of Rivipansel over 20 minutes<br>* Other names: GMI-1070;|
| Experimental: Normal Renal Functions<br>A single dose of IV Rivipansel over 20 minutes | Drug: Rivipansel<br>* A single 840mg dose of 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 concentration-time curve from time 0 to infinity or area under the concentration-time curve from time 0 to the 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, 72 and 96 H following single dose administration | 
| Clearance (CL) |  | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | 
| Renal clearance |  | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | 
| Physical examination |  | Baseline up to 96 hours | 
| Assessment of adverse events |  | Baseline up to 28 days | 
| Assessment of 12-lead electrocardiograms |  | Baseline up to 96 hours | 
| Assessment of vital signs |  | Baseline up to 96 hours | 
| Assessment of laboratory tests |  | Baseline up to 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration |  | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | 
| Peak or maximum observed concentration |  | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | 
| Time to reach maximum concentration |  | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | 
| Terminal half life |  | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | 
| Apparent volume of distribution |  | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | 
| Amount of unchanged drug excreted into urine over 96 hours |  | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | 
| Percentage of dose excreted unchanged into urine over 96 hours |  | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | 
| Fraction of unbound |  | Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Insufficiency