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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01485146
First received: October 25, 2011
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Safety Evaluation of Escalating Doses
Drug: ETC-1002
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ETC-1002 at Doses Above 120 mg/Day in Healthy Subjects

Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
8 Healthy Subjects in Phase I Unit
Drug: ETC-1002
escalating doses
Experimental: Cohort 2
8 Healthy Subjects in Phase I Unit
Drug: ETC-1002
escalating doses
Experimental: Cohort 3
8 Healthy Subjects in Phase I Unit
Drug: ETC-1002
escalating doses
Experimental: Cohort 4
8 Healthy Subjects in Phase I Unit
Drug: ETC-1002
escalating doses

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Major 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485146

Locations
United States, Michigan
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States
Sponsors and Collaborators
Esperion Therapeutics
  More Information

No publications provided

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01485146     History of Changes
Other Study ID Numbers: ETC-1002-004
Study First Received: October 25, 2011
Last Updated: April 12, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 29, 2014