A Study of Lanabecestat (LY3314814) in Healthy Participants

NCT ID: NCT02663128

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-03-31

Brief Summary

The purpose of this study is to measure how much of a new tablet formulation of lanabecestat gets into the blood stream and how long it takes the body to get rid of it, compared to the current tablet formulation of lanabecestat. The effect of a high fat meal on how quickly the body absorbs the new tablet formulation will also be evaluated. In addition any side effects of the study drug using both the new and current tablet formulations will be evaluated. The study will last about 22 days, with screening required within 30 days prior to the start of the study.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lanabecestat Reference Fasted

Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.

Group Type: EXPERIMENTAL

Lanabecestat

Intervention Type: DRUG

Administered orally

Lanabecestat Test Fasted

Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.

Group Type: EXPERIMENTAL

Lanabecestat

Intervention Type: DRUG

Administered orally

Lanabecestat Test Non Fasted

Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.

Group Type: EXPERIMENTAL

Lanabecestat

Intervention Type: DRUG

Administered orally

Interventions

Lanabecestat

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY3314814; AZD3293

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Other Identifiers

I8D-MC-AZEH

Identifier Type: OTHER

Identifier Source: secondary_id

16001

Identifier Type: -

Identifier Source: org_study_id