NCT01105598

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Esperion Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mild Dyslipidemia

Interventions

Type	Name	Description
DRUG	ETC-1002 or placebo	ETC-1002 (ascending dose), daily for 14 days
DRUG	ETC-1002 or placebo	ETC-1002 (optimized dose), daily for 28 days
DRUG	ETC-1002 or placebo	ETC-1002 (20 mg), daily for 14 days

Timeline

• Start date: 2010-04-20
• Primary completion: 2010-10-02
• Completion: 2010-10-02
• First posted: 2010-04-16
• Last updated: 2019-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study