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Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

NCT02080468 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-03-11

Study results available
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Summary

The primary objective of this study is to assess the effect of ethinyl estradiol (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and 2 primary metabolites, M1 and M3.

Conditions

  • Healthy

Interventions

DRUG

lomitapide

20 mg

DRUG

EE/norgestimate

1x0.035-mg EE/0.25-mg norgestimate tablet

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
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-19
Primary Completion
2014-04-24
Completion
2014-04-24

Countries

  • United States

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 NCT02080468 on ClinicalTrials.gov