NCT01359579
Terminated
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- varespladib methyl
- Conditions
- Renal Impairment
- Sponsor
- Anthera Pharmaceuticals
- Enrollment
- 28
- Locations
- 3
- Primary Endpoint
- Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Subjects with mild renal impairment
Intervention: varespladib methyl
Subjects with moderate renal impairment
Intervention: varespladib methyl
Subjects with normal renal function
Intervention: varespladib methyl
Subjects with severe renal impairment
Intervention: varespladib methyl
Outcomes
Primary Outcomes
Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function
Time Frame: 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 Outcomes
- Safety measures to include adverse events and changes in clinical laboratory results(From admistration of study drug through follow-up on Day 8)
Study Sites (3)
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