Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002

Esperion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemia

Treatments: Drug: [14C-ETC-1002]

Study type: Interventional

Funder types: Industry

Identifiers

NCT02044627

1002-011

Details and patient eligibility

About

This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002 and the routes and rates of excretion of [14C]-ETC-1002

Enrollment: 6 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Male Volunteers
• BMI 10-35 kg/m2

Exclusion criteria

• Hx of CV, renal, hepatic, chronic respiratory or GI disease
• Hx of drug or alcohol abuse
• smoking within 12 mos of screening

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

1 dose of [14C-ETC-1002]

Experimental group

Treatment:

Drug: [14C-ETC-1002]