Conditions: Intra-subject Variability of Pharmacokinetics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: yes

Brief summary:
Objectives:

To evaluate the intra-subject variability of the pharmacokinetics (PK) of single oral capsule doses of 20 mg lomitapide.

Detailed description:
This study will be a single centre, open-label study. It will comprise of 2 single oral doses with at least a 14-day washout between doses. Following the first dose subjects will be discharged from the unit for the remainder of the washout period. Subjects will be re-admitted to the unit on Day -1 (Period 2) and following an overnight fast they will be administered the second dose on Day 1 (Period 2). Subjects will be discharged from the unit following the 168 h PK blood draw.

Arms:
arm 1: It will comprise of 2 single oral doses with at least a 14-day washout between doses.

Interventions: intervention 1: lomitapide
Intervention descriptions: intervention 1: 20 mg dose

Protocol document: