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Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.

NCT02080455 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-03-10

Study results available
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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.

Conditions

  • Effect of Atorvastatin on the Pharmacokinetics of Lomitapide

Interventions

DRUG

lomitapide

20 mg dose

DRUG

Atorvastatin

80 mg

Sponsors & Collaborators

  • Aegerion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Sumeray, MD · Cheif Medical Officer

  • T. Alex King, MD, CPI · Covance

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-27
Primary Completion
2014-03-07
Completion
2014-03-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02080455 on ClinicalTrials.gov