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

October 18, 2019 updated by: AstraZeneca

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

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Covance Clinical Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • LY3314814
  • AZD3293

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

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2017

Primary Completion (Actual)

May 22, 2017

Study Completion (Actual)

May 22, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 18, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

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.

Clinical Trials on Healthy

Clinical Trials on Rosuvastatin

3
Subscribe