A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03506399
• Other study ID #: 16004
• Secondary ID: I8D-MC-AZEK
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2018
• Est. completion date: October 2018

Study information

• Verified date: June 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lanabecestat
Administered orally
• Oral Contraceptive
Administered orally

Locations

Country	Name	City	State
Singapore	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	AstraZeneca

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	PK: AUC of Levonorgestrel	PK: AUC of Levonorgestrel	Baseline though 120 hours after administration of the study drug (lanabecestat)
Primary	PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol	PK: Cmax of Ethinyl Estradiol	Baseline though 120 hours after administration of the study drug (lanabecestat)
Primary	PK: Cmax of Levonorgestrel	PK: Cmax of Levonorgestrel	Baseline though 120 hours after administration of the study drug (lanabecestat)