A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Lanabecestat on the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel in Healthy Female Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lanabecestat
* Drug: Oral Contraceptive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Contraceptive (OC)<br>Ethinyl estradiol and levonorgestrel administered as a single dose, orally | Drug: Oral Contraceptive<br>* Administered orally<br>* Other names: Ethinyl Estradiol and Levonorgestrel;|
| Experimental: Lanabecestat<br>Single oral dose of lanabecestat | Drug: Lanabecestat<br>* Administered orally<br>* Other names: LY3314814;|
| Experimental: Lanabecestat and OC<br>A single oral dose of oral contraceptive and single daily doses of lanabecestat | Drug: Lanabecestat<br>* Administered orally<br>* Other names: LY3314814;Drug: Oral Contraceptive<br>* Administered orally<br>* Other names: Ethinyl Estradiol and Levonorgestrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol | PK: AUC of Ethinyl Estradiol | Baseline though 120 hours after administration of the study drug (lanabecestat) | 
| PK: AUC of Levonorgestrel | PK: AUC of Levonorgestrel | Baseline though 120 hours after administration of the study drug (lanabecestat) | 
| PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol | PK: Cmax of Ethinyl Estradiol | Baseline though 120 hours after administration of the study drug (lanabecestat) | 
| PK: Cmax of Levonorgestrel | PK: Cmax of Levonorgestrel | Baseline though 120 hours after administration of the study drug (lanabecestat) |