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

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

Completed

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, NG11 6Js, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C-ETC-1002]

Drug

Primary outcomes

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

Time frame: 11 days

using mass balance recovery

Sponsors and collaborators

Lead sponsor

Esperion Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label,Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002 in Healthy Male Volunteers

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jan 24, 2014
Registry last updated: Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed