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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dabigatran etexilate; Drug: Lanabecestat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02568397

I8D-MC-AZEE (Other Identifier)

15997

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Dabigatran Etexilate

Experimental group

Description:

Single dose of dabigatran etexilate administered orally.

Treatment:

Drug: Dabigatran etexilate

Lanabecestat and Dabigatran Etexilate

Experimental group

Description:

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.

Treatment:

Drug: Lanabecestat

Drug: Dabigatran etexilate