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

Phase 1CompletedNCT02044627

Esperion Therapeutics, Inc.6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Hyperlipidemia

Interventions

[14C-ETC-1002]DRUG

Eligibility

Sex: MALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quotient Clinical

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Level of [14C]-ETC-1002 in urine and feces after a single dose

using mass balance recovery

Time frame: 11 days

Data from ClinicalTrials.gov

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