NCT01414881

Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects

A Phase 1 Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Kastle Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this Phase I exploratory study is to determine the effects of mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period, a 1-week Run-in Period to establish a stable diet, an approximate 11-week Treatment Period with Placebo or Mipomersen, and a 25-week Post-Treatment Follow-up Period. The total duration of any given subject's participation will be approximately 40 weeks.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	mipomersen	mipomersen 200mg subcutaneously (SC) once weekly
DRUG	Placebo	Placebo administered subcutaneously (SC) once weekly

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2012-11-01
• First posted: 2011-08-11
• Last updated: 2016-08-03

Locations

1 site across 1 country: United States