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14C-ETC-1002]

Phase 1

Hyperlipidemia | Unknown | Cardiovascular |Esperion Therapeutics, Inc.|Last Updated: Feb 15, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

14C-ETC-1002] · 1 trial · 1 indication

Phase 1 1
NCT02044627Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002Hyperlipidemia
COMPLETED6 Analytics
PHASE1COMPLETED
Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002
HyperlipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

using mass balance recovery

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
1 dose of [14C-ETC-1002]EXPERIMENTAL -

Interventions

NameTypeDescription
[14C-ETC-1002]DRUG -
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Eligibility Criteria

Age Range30 Years to 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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

Countries:United Kingdom
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Frequently asked questions about 14C-ETC-1002]

What is [14C-ETC-1002] used for in hyperlipidemia?

[14C-ETC-1002] is an investigational radiolabeled form of ETC-1002 being studied in hyperlipidemia. It is used in a Phase 1 clinical trial to investigate the absorption, metabolism and excretion of the drug. The study enrolled 6 healthy male volunteers aged 30 years and older in the United Kingdom.

Who makes [14C-ETC-1002]?

[14C-ETC-1002] is being developed by Esperion Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ESPR. The company is conducting a Phase 1 clinical trial of the drug in hyperlipidemia.

What phase is [14C-ETC-1002] in?

[14C-ETC-1002] is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial, which is completed, enrolled 6 participants and was conducted in the United Kingdom.

What clinical trials is [14C-ETC-1002] in?

[14C-ETC-1002] has one completed Phase 1 clinical trial registered as NCT02044627, titled 'Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002'. The study enrolled 6 healthy male volunteers with hyperlipidemia in the United Kingdom.

Is [14C-ETC-1002] the same as ETC-1002?

[14C-ETC-1002] is a radiolabeled version of ETC-1002, used specifically in a clinical study to track the drug's absorption, metabolism and excretion. The radiolabel allows researchers to follow the compound in the body. The Phase 1 trial NCT02044627 was designed to investigate these properties.