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

Anthera Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Renal Impairment

Treatments: Drug: varespladib methyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359579

AN-CVD2213

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Subjects with mild renal impairment

Experimental group

Treatment:

Drug: varespladib methyl

Subjects with moderate renal impairment

Experimental group

Treatment:

Drug: varespladib methyl

Subjects with normal renal function

Experimental group

Treatment:

Drug: varespladib methyl

Subjects with severe renal impairment

Experimental group

Treatment:

Drug: varespladib methyl