A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function

Study Overview
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Brief Summary
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The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.

Official Title
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A Phase 1, Open-label, Pharmacokinetic, Safety, and Tolerability Study of a Single Oral Dose of Varespladib Methyl in Subjects With Normal Renal Function, and Subjects With Mild, Moderate, or Severe Renal Impairment

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: varespladib methyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and non-pregnant, non-lactating females 18 years or older with a BMI of 18-40 kg/m2 inclusive. Regarding renal function, subjects will be classified as either normal or as suffering from mild,moderate or severe renal impairment. Classification of renal impairment will be estimated by the MDRD and Cockcroft-Gault formulae Exclusion Criteria: Any disease, condition and/or chronic medications which might compromise the hematologic, cardiovascular, pulmonary renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might interfere with the distribution, metabolism or excretion of study drug, or would place the subject at increased risk Evidence of significant respiratory, gastrointestinal or hepatic disease at screening Positive screen for hepatitis B surface antigen, or HIV Positive test in drugs of abuse screens or alcohol on admission to the clinic

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with mild renal impairment<br> | Drug: varespladib methyl<br>* Single oral 500 mg dose<br>|
| Experimental: Subjects with moderate renal impairment<br> | Drug: varespladib methyl<br>* Single oral 500 mg dose<br>|
| Experimental: Subjects with normal renal function<br> | Drug: varespladib methyl<br>* Single oral 500 mg dose<br>|
| Experimental: Subjects with severe renal impairment<br> | Drug: varespladib methyl<br>* Single oral 500 mg dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function |  | PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures to include adverse events and changes in clinical laboratory results |  | From admistration of study drug through follow-up on Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal impairment, phase 1, healthy volunteers