CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
lomitapide +1 moredrug
Likely dose
lomitapide 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02080468
NCT02080468Phase 1Completed
CompareCT.gov

A Phase 1, Open-Label, Randomized, 2-Arm Study to Evaluate the Effect of Ethinyl Estradiol/Norgestimate (Ortho Cyclen®), a Weak CYP3A4 Inhibitor, on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

Aegerion Pharmaceuticals, Inc.·interventional·Posted Mar 6, 2014·Updated Mar 11, 2019

In Brief

A Phase 1 clinical trial evaluating lomitapide and EE/norgestimate for Healthy. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 6, 2014
Enrollment StartFeb 19, 2014
Primary CompletionApr 24, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.3 years ago

Interventions

lomitapidedrug

20 mg

EE/norgestimatedrug

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