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NCT02080468 · ClinicalTrials.gov registry record · Phase 1
Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
A Phase 1 study, sponsored by Aegerion Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02080468 is a Phase 1 study that has completed, run by Aegerion Pharmaceuticals. The registered enrollment target is 32 participants.
The verdict
NCT02080468, a Phase 1 study, has completed, sponsored by Aegerion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study 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.
Interventions
- DRUG lomitapide
- DRUG EE/norgestimate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-02-19 |
| Est. Completion | 2014-04-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02080468
The ClinicalTrials.gov registry entry for NCT02080468 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aegerion Pharmaceuticals, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lomitapide is the first listed.
NCT02080468 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02080468 about?
NCT02080468 is a clinical study titled "Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects". 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.
What is the current status of trial NCT02080468?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2014-02-19. Estimated completion is 2014-04-24.
What interventions are being tested in trial NCT02080468?
The interventions under investigation include: lomitapide (DRUG), EE/norgestimate (DRUG).
Who is sponsoring clinical trial NCT02080468?
This trial is sponsored by Aegerion Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
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