- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03019549
A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With Rosuvastatin
Effect of LY3314814 on the Pharmacokinetics of Rosuvastatin in Caucasian Healthy Subjects
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Covance Clinical Research Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rosuvastatin
Period 1: 20 mg rosuvastatin administered once orally (PO)
|
Administered orally
|
Experimental: Lanabecestat + Rosuvastatin
Period 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8
|
Administered orally
Administered orally
Other Names:
|
What is the study measuring?
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
Time Frame: 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
|
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)
Time Frame: Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose
|
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
Time Frame: .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
|
.Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15994
- I8D-MC-AZEB (Other Identifier: Eli Lilly and Company.)
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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