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A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia

NCT01105598 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-03-28

No results posted yet for this study

Summary

This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.

Conditions

  • Mild Dyslipidemia

Interventions

DRUG

ETC-1002 or placebo

ETC-1002 (ascending dose), daily for 14 days

DRUG

ETC-1002 or placebo

ETC-1002 (optimized dose), daily for 28 days

DRUG

ETC-1002 or placebo

ETC-1002 (20 mg), daily for 14 days

Sponsors & Collaborators

  • Esperion Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jim C Khalifa, MD · Esperion Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-20
Primary Completion
2010-10-02
Completion
2010-10-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01105598 on ClinicalTrials.gov