Clinical trial NCT02663128: A Study of Lanabecestat (LY3314814) in Healthy Participants
Official title: A Bioequivalence and Food Effect Study in Healthy Subjects Administered 2 Different Tablet Formulations of LY3314814
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2016-01-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293)
timeFrame: 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
measure: PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293)
timeFrame: 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
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: