- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02663128
A Study of Lanabecestat (LY3314814) in Healthy Participants
A Bioequivalence and Food Effect Study in Healthy Subjects Administered 2 Different Tablet Formulations of LY3314814
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lanabecestat Reference Fasted
Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.
|
Administered orally
Other Names:
|
Experimental: Lanabecestat Test Fasted
Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.
|
Administered orally
Other Names:
|
Experimental: Lanabecestat Test Non Fasted
Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.
|
Administered orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293)
Time Frame: 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
|
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)
Time Frame: 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
|
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)
Time Frame: 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
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16001
- I8D-MC-AZEH (Other Identifier: Eli Lilly and Company)
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.
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