A Study of Lanabecestat (LY3314814) in Healthy Participants

NCT02663128 | Completed Phase 1 Results

• 2 other identifiers: 16001I8D-MC-AZEH
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293)

  Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose

• PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293)

  Day 1 of Periods 1, 2, and 3:Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293)

  Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose

Study Arms (3)

Lanabecestat Reference Fasted

EXPERIMENTAL

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

Drug: Lanabecestat

Lanabecestat Test Fasted

EXPERIMENTAL

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

Drug: Lanabecestat

Lanabecestat Test Non Fasted

EXPERIMENTAL

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

Drug: Lanabecestat

Interventions

Lanabecestat DRUG

Administered orally

Also known as: LY3314814, AZD3293

Lanabecestat Reference Fasted; Lanabecestat Test Fasted; Lanabecestat Test Non Fasted

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

MeSH Terms

Interventions

lanabecestat

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5079

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 26, 2016
• Study Start: January 31, 2016
• Primary Completion: March 31, 2016
• Study Completion: March 31, 2016
• Last Updated: November 1, 2019
• Results First Posted: March 22, 2019

Record last verified: 2019-10