NCT02568397

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

October 31, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

April 5, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

October 2, 2015

Results QC Date

December 13, 2018

Last Update Submit

October 18, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran

    Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

  • Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)

    Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Secondary Outcomes (4)

  • Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat

    Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose

  • Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)

    Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose

  • Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time

    Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

  • Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time

    Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Study Arms (2)

Dabigatran Etexilate

EXPERIMENTAL

Single dose of dabigatran etexilate administered orally.

Drug: Dabigatran etexilate

Lanabecestat and Dabigatran Etexilate

EXPERIMENTAL

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.

Drug: LanabecestatDrug: Dabigatran etexilate

Interventions

LanabecestatDRUG

Administered orally

Also known as: LY3314814, AZD3293
Lanabecestat and Dabigatran Etexilate
Dabigatran etexilateDRUG

Administered orally

Dabigatran EtexilateLanabecestat and Dabigatran Etexilate

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Overtly healthy males and females

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

lanabecestatDabigatran

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5079

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 5, 2015

Study Start

October 31, 2015

Primary Completion

January 31, 2016

Study Completion

January 31, 2016

Last Updated

November 1, 2019

Results First Posted

April 5, 2019

Record last verified: 2019-10

Locations

US(1)