A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With Rosuvastatin

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be measured. Information about any side effects that may occur will also be collected. Participants will be on study for 21 days with a follow-up at least 7 days afterwards. Screening will be undertaken within 45 days prior to enrollment.

Official Title
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Effect of LY3314814 on the Pharmacokinetics of Rosuvastatin in Caucasian Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lanabecestat
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women not of childbearing potential may participate and include those who are: Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or Postmenopausal - defined as women over 50 years of age with an intact uterus who have not taken hormones or oral contraceptives within 1 year, who have had either Spontaneous cessation of menses for at least 12 consecutive months, or 6 to 12 months of spontaneous amenorrhea with follicle-stimulating hormone level greater than (>)40 milli-international units per millilitre (mIU/mL) consistent with menopause Caucasian and may be of Hispanic ethnicity Body mass index (BMI) of 19 to 32 kilogram per meter square (kg/m²), inclusive, at the time of screening Exclusion Criteria: - Have a clinically significant abnormal blood pressure or heart rate (supine) as determined by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>Period 1: 20 mg rosuvastatin administered once orally (PO) | Drug: Rosuvastatin<br>* Administered orally<br>|
| Experimental: Lanabecestat + Rosuvastatin<br>Period 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8 | Drug: Lanabecestat<br>* Administered orally<br>* Other names: AZD3293;Drug: Rosuvastatin<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin | Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin | 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814) | Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814) | Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose | 
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat | .Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose |