Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 333 for:    DABIGATRAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568397
Recruitment Status : Completed
First Posted : October 5, 2015
Results First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lanabecestat Drug: Dabigatran etexilate Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of LY3314814 on the Pharmacokinetics of Dabigatran in Healthy Subjects
Study Start Date : October 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dabigatran Etexilate
Single dose of dabigatran etexilate administered orally.
Drug: Dabigatran etexilate
Administered orally

Experimental: 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.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Drug: Dabigatran etexilate
Administered orally




Primary Outcome Measures :
  1. Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose ]
  2. Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity) [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose ]
  2. Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau) [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose ]
  3. Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time [ Time Frame: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose ]
  4. Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time [ Time Frame: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose ]
    Ratio of maximum effect to baseline effect following administration of 150 mg dabigatran etexilate alone on Day 1, 50 mg LY3314814 and 150 mg dabigatran dosed concurrently on Day 16, and 50 mg LY3314814 and 150 mg dabigatran (dosed 4 hours later) on Day 20



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT02568397


Locations
Layout table for location information
United States, Texas
Covance
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02568397     History of Changes
Other Study ID Numbers: 15997
I8D-MC-AZEE ( Other Identifier: Eli Lilly and Company. )
First Posted: October 5, 2015    Key Record Dates
Results First Posted: April 5, 2019
Last Update Posted: April 5, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants