A study of lanabecestat (LY3314814) in healthy participants

Study identifier:16001

ClinicalTrials.gov identifier:NCT02663128

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Bioequivalence and Food Effect Study in Healthy Subjects Administered 2 Different Tablet Formulations of LY3314814

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Lanabecestat

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 85 Years

Date

Study Start Date: 31 Jan 2016

Primary Completion Date: 31 Mar 2016

Study Completion Date: 31 Mar 2016

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Oct 2019 by AstraZeneca

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

Inclusion Criteria

- Male participants:
Will be sterile (including vasectomy) or agree to use an effective method of
birth control and will not donate sperm during the study and for 3 months
following the last dose of the investigational product
- Female participants:
Women not of childbearing potential due to surgical sterilization or confirmed by medical history or menopause
- Are able to eat a high-fat, high-calorie meal within the defined time limit and
abide by the food restrictions throughout the study

Exclusion Criteria

- Have a history of or current, significant ophthalmic disease, as determined by the investigator or ophthalmologist
- Have vitiligo or any other clinically significant disorder of skin pigmentation as determined by the investigator or dermatologist
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- History of previous or ongoing psychiatric disease/condition
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study, or have a history of significant dysrhythmias or atrioventricular (AV) block (including first degree AV block). Participants with history of persistent PR interval greater than (>)200 milliseconds (msec) will be excluded
- Have prolonged Fridericia-corrected QT interval (QTcF) of >470 msec
- Have a clinically significant abnormal blood pressure or heart rate (supine) as
determined by the investigator
- Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Are unwilling to comply with the dietary requirements/restrictions during the study
- Evidence of active renal disease (e.g, diabetic renal disease, polycystic kidney disease) or calculated creatinine clearance <50 milliliters per minute (mL/min)

No locations available

Arms	Assigned Interventions
Experimental: Lanabecestat Reference Fasted Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.	Drug: Lanabecestat Administered orally Other Name: LY3314814 Other Name: AZD3293
Experimental: Lanabecestat Test Fasted Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.	Drug: Lanabecestat Administered orally Other Name: LY3314814 Other Name: AZD3293
Experimental: Lanabecestat Test Non Fasted Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.	Drug: Lanabecestat Administered orally Other Name: LY3314814 Other Name: AZD3293

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)