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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02044627

Enrollment

Registered

2014-01-24

Start date

2013-12-31

Completion date

2014-01-31

Last updated

2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

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

Interventions

DRUG[14C-ETC-1002]

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026