NCT01915771

Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects

A Phase 1, Open-label, Crossover Study to Determine the Intra-subject Variability of the Pharmacokinetics of Single Oral CapsuleDose of 20 mg Lomitapide in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Aegerion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intra-subject Variability of Pharmacokinetics

Interventions

Type	Name	Description
DRUG	lomitapide	20 mg dose

Timeline

• Start date: 2013-07-29
• Primary completion: 2013-08-23
• Completion: 2013-08-23
• First posted: 2013-08-05
• Last updated: 2020-03-11
• Results posted: 2020-03-11

Locations

1 site across 1 country: United Kingdom