A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia

A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETC-1002 in Subjects With Mild Dyslipidemia

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01105598

Enrollment

Registered

2010-04-16

Start date

2010-04-20

Completion date

2010-10-02

Last updated

2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Dyslipidemia

Brief summary

This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.

Interventions

DRUGETC-1002 or placebo

ETC-1002 (ascending dose), daily for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects of non-child bearing potential as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements * Fasting low density lipoprotein-cholesterol (LDL-C) of 100-160 mg/dL * Fasting triglycerides (TG) of 100-350 mg/dL (Cohort 5 only) * Body Mass Index (BMI) of 18-32 kg/m2 (Cohort 1 to 4 only) or 18-36 (Cohort 5 only) and body weight \>50 kg

Exclusion criteria

* Clinically significant disease that requires a physician's care and/or would interfere with study evaluations * Alanine aminotransferase (ALT) or aspartate amino transferase (AST) \>1.2 x ULN; serum creatinine \>ULN; hemoglobin \<12.0 g/dL; other clinical lab tests (with the exception of ALT, AST, serum creatinine and hemoglobin) outside normal or protocol specified limits that are determined by the Investigator to be clinically significant * Use of tobacco or tobacco products * Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization with the exception of lipid regulating drugs or supplements containing niacin \>500 mg/day or fish oil which will not have been used for 3 months prior to randomization * Other

Design outcomes

Primary

Measure	Time frame
Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values	14 or 28 days

Secondary

Measure	Time frame	Description
Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints	14 or 28 days	Pharmacodynamic endpoints include total cholesterol, low density lipoprotein-cholesterol (LDL-C), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C) and free fatty acids (FFA)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026