NCT03506399

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

April 20, 2018

Last Update Submit

June 26, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • 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)

Study Arms (3)

Oral Contraceptive (OC)

EXPERIMENTAL

Ethinyl estradiol and levonorgestrel administered as a single dose, orally

Drug: Oral Contraceptive

Lanabecestat

EXPERIMENTAL

Single oral dose of lanabecestat

Drug: Lanabecestat

Lanabecestat and OC

EXPERIMENTAL

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

Drug: LanabecestatDrug: Oral Contraceptive

Interventions

LanabecestatDRUG

Administered orally

Also known as: LY3314814
LanabecestatLanabecestat and OC
Oral ContraceptiveDRUG

Administered orally

Also known as: Ethinyl Estradiol and Levonorgestrel
Lanabecestat and OCOral Contraceptive (OC)

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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.

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

lanabecestatContraceptives, Oralethinyl estradiol, levonorgestrel drug combination

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2018

First Posted

April 24, 2018

Study Start

June 1, 2018

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

SG(1)