A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive

Lilly

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: Oral Contraceptive; Drug: Lanabecestat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03506399

16004

I8D-MC-AZEK (Other Identifier)

Details and patient eligibility

About

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.

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Oral Contraceptive (OC)

Experimental group

Description:

Ethinyl estradiol and levonorgestrel administered as a single dose, orally

Treatment:

Drug: Oral Contraceptive

Lanabecestat

Experimental group

Description:

Single oral dose of lanabecestat

Treatment:

Drug: Lanabecestat

Lanabecestat and OC

Experimental group

Description:

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

Treatment:

Drug: Lanabecestat

Drug: Oral Contraceptive