Back to resultsA Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
Primary Purpose
Renal Impairment
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
varespladib methyl
Sponsored by
About this trial
This is an interventional basic science trial for Renal Impairment focused on measuring renal impairment, phase 1, healthy volunteers
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
Sites / Locations
- Investigator Site 101
- Investigator Site 102
- Investigator Site 103
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Subjects with mild renal impairment
Subjects with moderate renal impairment
Subjects with normal renal function
Subjects with severe renal impairment
Arm Description
Outcomes
Primary Outcome Measures
Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function
Secondary Outcome Measures
Safety measures to include adverse events and changes in clinical laboratory results
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01359579
Brief Title
A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anthera Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
renal impairment, phase 1, healthy volunteers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with mild renal impairment
Arm Type
Experimental
Arm Title
Subjects with moderate renal impairment
Arm Type
Experimental
Arm Title
Subjects with normal renal function
Arm Type
Experimental
Arm Title
Subjects with severe renal impairment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
varespladib methyl
Intervention Description
Single oral 500 mg dose
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Safety measures to include adverse events and changes in clinical laboratory results
Time Frame
From admistration of study drug through follow-up on Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Investigator Site 101
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Investigator Site 102
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Investigator Site 103
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
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