A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2018-10-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Oral Contraceptive (OC)

Ethinyl estradiol and levonorgestrel administered as a single dose, orally

Group Type EXPERIMENTAL

Oral Contraceptive

Intervention Type DRUG

Administered orally

Lanabecestat

Single oral dose of lanabecestat

Group Type EXPERIMENTAL

Lanabecestat

Intervention Type DRUG

Administered orally

Lanabecestat and OC

A single oral dose of oral contraceptive and single daily doses of lanabecestat

Group Type EXPERIMENTAL

Lanabecestat

Intervention Type DRUG

Administered orally

Oral Contraceptive

Intervention Type DRUG

Administered orally

Interventions

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Lanabecestat

Administered orally

Intervention Type DRUG

Oral Contraceptive

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY3314814 Ethinyl Estradiol and Levonorgestrel

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes