A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
Stopped early · Phase 1
Conditions studied: Renal Impairment
In brief
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.
Key facts
- Study ID
- NCT01359579
- Run by
- Anthera Pharmaceuticals
- People needed
- 28
- Starts
- 2011-06-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2012-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Investigator Site 101 — Orlando, Florida, United States
- Investigator Site 102 — Minneapolis, Minnesota, United States
- Investigator Site 103 — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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