NCT01487460

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients

A First-in-human Randomized, Double-blind, Placebo-controlled, 4-part Study to Assess Safety, Tolerability, Pharmacokinetics (Including Open Label Study of Food Effect and Interaction With Simvastatin) and Pharmacodynamics of Interwoven Single- and Multiple-ascending Doses of TAP311 in Healthy Subjects and Dyslipidemic Patients.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.

Conditions

• Dyslipidemia
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAP311

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-12-07
• Last updated: 2020-12-21

Locations

1 site across 1 country: United States