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

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ClinicalTrials.gov Identifier: NCT02044627
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: [14C-ETC-1002] Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Study Start Date : December 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: 1 dose of [14C-ETC-1002] Drug: [14C-ETC-1002]



Primary Outcome Measures :
  1. Level of [14C]-ETC-1002 in urine and feces after a single dose [ Time Frame: 11 days ]
    using mass balance recovery



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044627


Locations
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United Kingdom
Quotient Clinical
Nottingham, United Kingdom, NG11 6Js
Sponsors and Collaborators
Esperion Therapeutics, Inc.
Investigators
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Principal Investigator: Stuart Mair, MBChB, DRCOG, DCPSA, MFPM Quotient Clinical, Mere Way, Ruddington Fields, Ruddington, Nottinham NG11 6JS, UK
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Responsible Party: Esperion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02044627    
Other Study ID Numbers: 1002-011
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs