Conditions: Effect of Atorvastatin on the Pharmacokinetics of Lomitapide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: 2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 \& Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 11 through day 21) arm 2: 2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 \& Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 12 through day 22)

Interventions: intervention 1: lomitapide intervention 2: Atorvastatin
Intervention descriptions: intervention 1: 20 mg dose intervention 2: 80 mg

Protocol document: