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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01485146
First Posted: December 5, 2011
Last Update Posted: April 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Esperion Therapeutics
  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
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood. [ Time Frame: 14 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485146


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

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01485146     History of Changes
Other Study ID Numbers: ETC-1002-004
First Submitted: October 25, 2011
First Posted: December 5, 2011
Last Update Posted: April 13, 2012
Last Verified: April 2012