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A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled

NCT02044419 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-02-13

Study results available
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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

DRUG

lomitapide

Sponsors & Collaborators

  • Aegerion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Sumeray, MD · Aegerion Pharmaceuticals, Inc.

  • Ulrike Lorch, MD · Richmond Phamacology, LTD

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-30
Primary Completion
2013-12-23
Completion
2013-12-23

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02044419 on ClinicalTrials.gov