Healthy
Conditions
Brief summary
The study will evaluate the effect of oral contraceptive (birth control pill) on the blood level of lanabecestat when both are given together. Side effects will be monitored and documented. This study will last up to 27 days for each participant, not including screening. Screening is required within 42 days prior to first dose.
Interventions
DRUGLanabecestat
Administered orally
DRUGOral Contraceptive
Administered orally
Sponsors
AstraZeneca
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are healthy female participants * Women not of childbearing potential; women of childbearing potential using a non-hormonal intrauterine device (IUD) * Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square (kg/m²)
Exclusion criteria
* Have a history of or current significant ophthalmic disease, which includes participants with clinically significant eye abnormalities, particularly any eye problem involving the retina, as determined by the investigator * Have vitiligo or any other clinically significant disorder of skin or hair pigmentation, as determined by the investigator * Have a history of or current neuropsychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state, or personality disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol | Baseline though 120 hours after administration of the study drug (lanabecestat) | PK: AUC of Ethinyl Estradiol |
| PK: AUC of Levonorgestrel | Baseline though 120 hours after administration of the study drug (lanabecestat) | PK: AUC of Levonorgestrel |
| PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol | Baseline though 120 hours after administration of the study drug (lanabecestat) | PK: Cmax of Ethinyl Estradiol |
| PK: Cmax of Levonorgestrel | Baseline though 120 hours after administration of the study drug (lanabecestat) | PK: Cmax of Levonorgestrel |
Countries
Singapore
Outcome results
None listed