A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is to study the effect of lanabecestat on how the body absorbs and processes 3 other medications, midazolam, simvastatin and donepezil and how these 3 medications affect lanabecestat when they are taken together. This study is in 2 cohorts, Cohort A is approximately 44 days long and Cohort B about 70 days only. The screening visit is required within 30 days prior to the start on the study

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Detailed Description

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Astra Zeneca (AZ) registered this trial as sponsor. In July, 2015, sponsorship changed to Eli Lilly and Company (Lilly). In August, 2015, AZ transferred this trial to Lilly's ClinicalTrials.gov account and Lilly updated the record. This trial is not an applicable trial under the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Lanabecestat

Intervention Type DRUG

50 mg lanabecestat will be administered orally as 1 × 50-mg tablet

Simvastatin

Intervention Type DRUG

20 mg simvastatin will be administered orally as 1 × 20-mg tablet

Midazolam

Intervention Type DRUG

500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup

Midazolam

Intervention Type DRUG

250 mcg midazolam will be administered intravenous (IV) as 0.25 mL of 1-mg/mL injection solution

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

Group Type EXPERIMENTAL

Donepezil

Intervention Type DRUG

5 mg donepezil will be administered orally as 1 × 5-mg tablet

Lanabecestat

Intervention Type DRUG

50 mg lanabecestat will be administered orally as 1 × 50-mg tablet

Interventions

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Lanabecestat

50 mg lanabecestat will be administered orally as 1 × 50-mg tablet

Intervention Type DRUG

Simvastatin

20 mg simvastatin will be administered orally as 1 × 20-mg tablet

Intervention Type DRUG

Midazolam

500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup

Intervention Type DRUG

Midazolam

250 mcg midazolam will be administered intravenous (IV) as 0.25 mL of 1-mg/mL injection solution

Intervention Type DRUG

Donepezil

5 mg donepezil will be administered orally as 1 × 5-mg tablet

Intervention Type DRUG

Lanabecestat

50 mg lanabecestat will be administered orally as 1 × 50-mg tablet

Intervention Type DRUG

Other Intervention Names

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LY3314814 AZD3293 LY3314814 AZD3293

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes