Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002
Phase 1
Completed
- Conditions
- Hyperlipidemia
- Interventions
- Drug: [14C-ETC-1002]
- Registration Number
- NCT02044627
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 dose of [14C-ETC-1002] [14C-ETC-1002] -
- Primary Outcome Measures
Name Time Method Level of [14C]-ETC-1002 in urine and feces after a single dose 11 days using mass balance recovery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Clinical
🇬🇧Nottingham, United Kingdom
Quotient Clinical🇬🇧Nottingham, United Kingdom