A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive
- Registration Number
- NCT03506399
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lanabecestat Lanabecestat Single oral dose of lanabecestat Oral Contraceptive (OC) Oral Contraceptive Ethinyl estradiol and levonorgestrel administered as a single dose, orally Lanabecestat and OC Oral Contraceptive A single oral dose of oral contraceptive and single daily doses of lanabecestat Lanabecestat and OC Lanabecestat A single oral dose of oral contraceptive and single daily doses of lanabecestat
- Primary Outcome Measures
Name Time Method PK: AUC of Levonorgestrel Baseline though 120 hours after administration of the study drug (lanabecestat) PK: AUC of Levonorgestrel
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol Baseline though 120 hours after administration of the study drug (lanabecestat) PK: AUC of Ethinyl Estradiol
PK: Cmax of Levonorgestrel Baseline though 120 hours after administration of the study drug (lanabecestat) PK: Cmax of Levonorgestrel
PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol Baseline though 120 hours after administration of the study drug (lanabecestat) PK: Cmax of Ethinyl Estradiol
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (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, Singapore