Conditions: Healthy
Keywords: Effect Ethinyl Estradiol/Norgestimate Pharmacokinetics Lomitapide.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: yes

Brief 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.

Detailed description:
This study will be a single center, randomized, open-label, 2 arm study to evaluate the effects of EE/norgestimate, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy female subjects when EE/norgestimate is administered simultaneously with lomitapide and when administration is separated by 12 hours.

Arms:
arm 1: Lomitapide \& EE/Norgestimate - Taken Together 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28) arm 2: Lomitapide \& EE/Norgestimate - Taken 12 hours apart 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29)

Interventions: intervention 1: lomitapide intervention 2: EE/norgestimate
Intervention descriptions: intervention 1: 20 mg intervention 2: 1x0.035-mg EE/0.25-mg norgestimate tablet

Protocol document: