drugset / Trial / NCT02080468
Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
RandomizedParallel-groupOpen-labelOther
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.
Timeline
- Start
- 2014-02-19
- Primary completion
- 2014-04-24
- Completion
- 2014-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Norgestimate | Small molecule | 0.25 mg | — |
| Subject | ethinyl estradiol | Small molecule | 0.035 mg | — |
| Subject | lomitapide | Small molecule | 20 mg | Oral |
Indications
No indication recorded.