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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Rosuvastatin; Drug: Lanabecestat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03019549

I8D-MC-AZEB (Other Identifier)

15994

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Rosuvastatin

Experimental group

Description:

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

Treatment:

Drug: Rosuvastatin

Lanabecestat + Rosuvastatin

Experimental group

Description:

Period 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8

Treatment:

Drug: Lanabecestat

Drug: Rosuvastatin