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

February 13, 2019 updated by: Esperion Therapeutics, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG11 6JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esperion Therapeutics, Inc.

Investigators

  • Principal Investigator: Stuart Mair, MBChB, DRCOG, DCPSA, MFPM, Quotient Clinical, Mere Way, Ruddington Fields, Ruddington, Nottinham NG11 6JS, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1002-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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