A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ETC-1002 at Doses Above 120 mg/Day in Healthy Subjects

Esperion Therapeutics, Inc.1 site in 1 country24 target enrollmentOctober 25, 2011

ConditionsSafety Evaluation of Escalating Doses

InterventionsETC-1002

DrugsETC-1002

Overview

Phase: Phase 1
Intervention: ETC-1002
Conditions: Safety Evaluation of Escalating Doses
Sponsor: Esperion Therapeutics, Inc.
Enrollment: 24
Locations: 1
Primary Endpoint: Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects.

Registry

clinicaltrials.gov

Start Date

October 25, 2011

End Date

January 25, 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Esperion Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements
•Body Mass Index of 18-32 kg/m2 inclusive with body weight \>50 kg

Exclusion Criteria

•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.2 x Upper Limit of Normal(ULN), serum creatinine \>ULN, Hemoglobin \<12.0 g/dL
•Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
•History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization
•Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization
•Other exclusion criteria apply