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Completed

NCT Number: NCT01485146

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

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.

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Key information

Conditions

Safety Evaluation of Escalating Doses

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETC-1002

Drug

escalating doses

Primary outcomes

  1. Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures.

    Time frame: 14 days

Secondary outcomes

  1. Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood.

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Esperion Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2011
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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