A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive

June 26, 2018 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 138623
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oral Contraceptive (OC)
Ethinyl estradiol and levonorgestrel administered as a single dose, orally
Administered orally
Other Names:
  • Ethinyl Estradiol and Levonorgestrel
EXPERIMENTAL: Lanabecestat
Single oral dose of lanabecestat
Administered orally
Other Names:
  • LY3314814
EXPERIMENTAL: Lanabecestat and OC
A single oral dose of oral contraceptive and single daily doses of lanabecestat
Administered orally
Other Names:
  • LY3314814
Administered orally
Other Names:
  • Ethinyl Estradiol and Levonorgestrel

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2018

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

October 1, 2018

Study Registration Dates

First Submitted

April 20, 2018

First Submitted That Met QC Criteria

April 20, 2018

First Posted (ACTUAL)

April 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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