NCT02080455

Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.

A Phase 1, Open-Label, Randomized, 2-Arm Study to Evaluate the Effect of Atorvastatin, a Weak CYP3A4 Inhibitor, on the Pharmacokinetics of Lomitapide in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Aegerion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the effect of atorvastatin, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and its 2 primary metabolites, M1 and M3.

Detailed description

This study will be a single center, randomized, open-label, 2-arm study to evaluate the effects of atorvastatin, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy male and female subjects when atorvastatin is administered simultaneously with lomitapide and when it is administered 12 hours after lomitapide.

Conditions

• Effect of Atorvastatin on the Pharmacokinetics of Lomitapide

Interventions

Type	Name	Description
DRUG	lomitapide	20 mg dose
DRUG	Atorvastatin	80 mg

Timeline

• Start date: 2014-01-27
• Primary completion: 2014-03-07
• Completion: 2014-03-07
• First posted: 2014-03-06
• Last updated: 2020-03-10
• Results posted: 2020-03-10

Locations

1 site across 1 country: United States