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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this study is to learn about the effect of lanabecestat on how the body absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat when they are taken together. This study will last about 28 days and participants will be asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3 occasions. Screening is required within 30 days prior to the start of the study.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dabigatran Etexilate

Single dose of dabigatran etexilate administered orally.

Group Type EXPERIMENTAL

Dabigatran etexilate

Intervention Type DRUG

Administered orally

Lanabecestat and Dabigatran Etexilate

Single dose of lanabecestat administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the lanabecestat dosing.

Group Type EXPERIMENTAL

Lanabecestat

Intervention Type DRUG

Administered orally

Dabigatran etexilate

Intervention Type DRUG

Administered orally

Interventions

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Lanabecestat

Administered orally

Intervention Type DRUG

Dabigatran etexilate

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY3314814 AZD3293

Eligibility Criteria

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Inclusion Criteria

\- Overtly healthy males and females

Exclusion Criteria

* Eye abnormalities or disease
* History of vitiligo or any skin color disorder
* Have a history psychiatric or brain disease including seizures
* Have smoked within the last 3 months
* Are unwilling to avoid food and drinks containing grapefruit or Seville oranges for the duration of the study
* Have known allergies to dabigatran etexilate and related compounds

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes