Back to resultsSingle Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
[14C-ETC-1002]
Sponsored by
About this trial
This is an interventional diagnostic trial for Hyperlipidemia
Eligibility 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
Sites / Locations
- Quotient Clinical
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 dose of [14C-ETC-1002]
Arm Description
Outcomes
Primary Outcome Measures
Level of [14C]-ETC-1002 in urine and feces after a single dose
using mass balance recovery
Secondary Outcome Measures
Full Information
NCT ID
NCT02044627
First Posted
January 21, 2014
Last Updated
February 13, 2019
Sponsor
Esperion Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02044627
Brief Title
Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002
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 Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Esperion Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 dose of [14C-ETC-1002]
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[14C-ETC-1002]
Primary Outcome Measure Information:
Title
Level of [14C]-ETC-1002 in urine and feces after a single dose
Description
using mass balance recovery
Time Frame
11 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Mair, MBChB, DRCOG, DCPSA, MFPM
Organizational Affiliation
Quotient Clinical, Mere Way, Ruddington Fields, Ruddington, Nottinham NG11 6JS, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Clinical
City
Nottingham
ZIP/Postal Code
NG11 6Js
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002
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