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

NCT ID: NCT02044627

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1 dose of [14C-ETC-1002]

Group Type EXPERIMENTAL

[14C-ETC-1002]

Intervention Type DRUG

Interventions

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[14C-ETC-1002]

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Esperion Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stuart Mair, MBChB, DRCOG, DCPSA, MFPM

Role: PRINCIPAL_INVESTIGATOR

Quotient Clinical, Mere Way, Ruddington Fields, Ruddington, Nottinham NG11 6JS, UK

Locations

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Quotient Clinical

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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1002-011

Identifier Type: -

Identifier Source: org_study_id

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