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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044627
• Other study ID #: 1002-011
• Status: Completed
• Phase: Phase 1
• Start date: December 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2019
• Source: Esperion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• [14C-ETC-1002]

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Esperion Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of [14C]-ETC-1002 in urine and feces after a single dose	using mass balance recovery	11 days