A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants
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ClinicalTrials.gov Identifier: NCT02406261 |
Recruitment Status :
Completed
First Posted : April 2, 2015
Results First Posted : March 22, 2019
Last Update Posted : November 4, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Lanabecestat Drug: Simvastatin Drug: Midazolam Drug: Donepezil | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Study to Characterize LY3314814 Pharmacokinetics as a Function of Dosing Duration and to Determine the Effect of LY3314814 on the Pharmacokinetics of CYP3A Substrates in Healthy Subjects |
Actual Study Start Date : | April 30, 2015 |
Actual Primary Completion Date : | August 31, 2015 |
Actual Study Completion Date : | August 31, 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort A
500 microgram (mcg) midazolam, single oral dose on Days 1, 17, and 35; 20 mg simvastatin, single oral dose on Days 2 and 36; 250 microgram (mcg) midazolam, intravenous (IV) on Days 3 and 37; 50 mg lanabecestat, single oral dose on Day 4; 50 mg lanabecestat, single oral dose, Days 10 to 37 |
Drug: Lanabecestat
50 mg lanabecestat will be administered orally as 1 × 50-mg tablet
Other Names:
Drug: Simvastatin 20 mg simvastatin will be administered orally as 1 × 20-mg tablet Drug: Midazolam 500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup Drug: Midazolam 250 mcg midazolam will be administered intravenous (IV) as 0.25 mL of 1-mg/mL injection solution |
Experimental: Cohort B
5 mg donepezil, single oral dose on Day 1, Period 1; 50 mg lanabecestat, single oral dose Days 1 to 43, Period 2; 5 mg donepezil, single oral dose on Day 28, Period 2 |
Drug: Donepezil
5 mg donepezil will be administered orally as 1 × 5-mg tablet Drug: Lanabecestat 50 mg lanabecestat will be administered orally as 1 × 50-mg tablet
Other Names:
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- Pharmacokinetic (PK): Area Under the Curve Zero to Infinity (AUC[0-∞]) for LY3314814 [ Time Frame: Day 4: Predose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours (Cohort A) ]
- PK Profile for Simvastatin: AUC(0-∞) [ Time Frame: Day 2 and 36: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours (Cohort A) ]
- PK Profile for Midazolam: AUC(0-∞) Oral and IV Dose [ Time Frame: Day 1, 3, 17, 35, and 37: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, and 12 hours (Cohort A) ]
- PK Profile for Donepezil: AUC(0-∞) [ Time Frame: Day 1 and 28: predose 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96,120, 216, 288, and 360 hours (Cohort B) ]
- Number of Participants With One or More Serious Adverse Events(s) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Cohort A : Baseline to Study Completion (Up to Day 50); Cohort B: Baseline to Study Completion (Up to Day 70) ]
- Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Cohort A: Baseline to Study Completion (Up to Day 50); Cohort B: Baseline to Study Completion (Up to Day 70) ]C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Overtly healthy and either sterile or, male and prepared to use an approved method of contraception
- Have a body mass index (BMI) at screening of 19.0 to 32.0 kilogram per square meter (kg/m^2)
Exclusion Criteria:
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the results, or may limit the subject's ability to participate in the study
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406261
United States, Florida | |
Covance Inc | |
Daytona Beach, Florida, United States, 32117 | |
United States, Texas | |
Covance Inc | |
Dallas, Texas, United States, 75247 |
Study Director: | 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 |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT02406261 |
Other Study ID Numbers: |
16014 I8D-MC-AZER ( Other Identifier: Eli Lilly and Company ) |
First Posted: | April 2, 2015 Key Record Dates |
Results First Posted: | March 22, 2019 |
Last Update Posted: | November 4, 2019 |
Last Verified: | October 2019 |
Midazolam Donepezil Simvastatin Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics |
GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Cholinesterase Inhibitors Cholinergic Agents Nootropic Agents |