Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects

Anthera Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: varespladib methyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359605

AN-CVD2215

Details and patient eligibility

About

The purpose of the study is to characterize the metabolism and excretion (ADME) of a single oral dose of [14C]varespladib methyl.

Enrollment: 6 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed, written and dated informed consent prior to any study specific procedure
• Healthy males, 19 to 55 years of age
• Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive

Exclusion criteria

• History or presence of any clinically significant disease or disorder in the opinion of the investigator
• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, or vital signs at baseline in the opinion of the investigator

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

varespladib methyl

Experimental group

Treatment:

Drug: varespladib methyl