NCT02044627

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1 month

First QC Date

January 21, 2014

Last Update Submit

February 13, 2019

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Level of [14C]-ETC-1002 in urine and feces after a single dose

    using mass balance recovery

    11 days

Study Arms (1)

1 dose of [14C-ETC-1002]

EXPERIMENTAL
Drug: [14C-ETC-1002]

Interventions

[14C-ETC-1002]DRUG
1 dose of [14C-ETC-1002]

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Male Volunteers
  • BMI 10-35 kg/m2

You may not qualify if:

  • Hx of CV, renal, hepatic, chronic respiratory or GI disease
  • Hx of drug or alcohol abuse
  • smoking within 12 mos of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6Js, United Kingdom

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Stuart Mair, MBChB, DRCOG, DCPSA, MFPM

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 24, 2014

Study Start

December 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

GB(1)