NCT02044419

A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled

A Phase 1, Open-label, Randomised, Crossover Study to Determine the Comparative Bioavailability of 20 mg Lomitapide Where the Contents Have Been Opened and Sprinkled in Applesauce or Mashed Banana ("Sprinkled Contents") to a Single Oral Capsule Dose of 20 mg Lomitapide ("Intact Capsule") in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Aegerion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To compare the relative bioavailability of lomitapide when administered by sprinkling the contents of a 20 mg capsule of lomitapide in applesauce or in mashed banana to a single oral intact capsule dose of 20 mg lomitapide in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	lomitapide

Timeline

• Start date: 2013-10-30
• Primary completion: 2013-12-23
• Completion: 2013-12-23
• First posted: 2014-01-24
• Last updated: 2018-02-13
• Results posted: 2018-02-13

Locations

1 site across 1 country: United Kingdom