Single Radiolabeled Dose Study to Investigate the Absorpt... | NCT02044627

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

NCT02044627

Sponsor

Esperion Therapeutics, Inc.

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

6Actual

Phase

Phase 1

Conditions

Hyperlipidemia

Interventions

[14C-ETC-1002]

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Jan 21, 2014

First Submission Date that Met QC Criteria

Jan 22, 2014

First Posted Date

Jan 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2019

Last Update Posted Date

Feb 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Label	Type	Description	Intervention Names
1 dose of [14C-ETC-1002]	Experimental		Drug: [14C-ETC-1002]

Name	Type	Description	Arm Group Labels	Other Names
[14C-ETC-1002]	Drug		1 dose of [14C-ETC-1002]

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stuart Mair, MBChB, DRCOG, DCPSA, MFPM	Quotient Clinical, Mere Way, Ruddington Fields, Ruddington, Nottinham NG11 6JS, UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Quotient Clinical		Nottingham		NG11 6Js	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided