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

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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)

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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