A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive

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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Withdrawn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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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