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

Phase 1
Completed
Conditions
Healthy
Interventions
Registration Number
NCT03019549
Lead Sponsor
AstraZeneca
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
42
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
RosuvastatinRosuvastatinPeriod 1: 20 mg rosuvastatin administered once orally (PO)
Lanabecestat + RosuvastatinLanabecestatPeriod 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8
Lanabecestat + RosuvastatinRosuvastatinPeriod 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8
Primary Outcome Measures
NameTimeMethod
Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin1, 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

Secondary Outcome Measures
NameTimeMethod
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

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat

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): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)

Trial Locations

Locations (1)

Covance Clinical Research Inc

🇺🇸

Daytona Beach, Florida, United States

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