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

Esperion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Safety Evaluation of Escalating Doses

Treatments: Drug: ETC-1002

Study type: Interventional

Funder types: Industry

Identifiers

NCT01485146

ETC-1002-004

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Cohort 1

Experimental group

Description:

8 Healthy Subjects in Phase I Unit

Treatment:

Drug: ETC-1002

Cohort 2

Experimental group

Description:

8 Healthy Subjects in Phase I Unit

Treatment:

Drug: ETC-1002

Cohort 3

Experimental group

Description:

8 Healthy Subjects in Phase I Unit

Treatment:

Drug: ETC-1002