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
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 April 22, 2014