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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-12

Study Completion Date

2017-05-22

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Rosuvastatin

Period 1: 20 mg rosuvastatin administered once orally (PO)

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Administered orally

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

Group Type EXPERIMENTAL

Lanabecestat

Intervention Type DRUG

Administered orally

Rosuvastatin

Intervention Type DRUG

Administered orally

Interventions

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Lanabecestat

Administered orally

Intervention Type DRUG

Rosuvastatin

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY3314814 AZD3293

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