A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects

Phase 1

Completed

• Conditions: Safety Evaluation of Escalating Doses
• Interventions: Drug: ETC-1002

• Registration Number: NCT01485146
• Lead Sponsor: Esperion Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-25
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Primary Completion: 2012-01-25
• Study Completion: 2012-01-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Major

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	ETC-1002	8 Healthy Subjects in Phase I Unit
Cohort 3	ETC-1002	8 Healthy Subjects in Phase I Unit
Cohort 2	ETC-1002	8 Healthy Subjects in Phase I Unit

Primary Outcome Measures

Name	Time	Method
Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures.	14 days

Secondary Outcome Measures

Name	Time	Method
Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood.	14 days

Trial Locations

Locations (1)

Jasper Clinic, Inc.; 🇺🇸 Kalamazoo, Michigan, United States