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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Lanabecestat
Drug: Dabigatran etexilate
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dabigatran Etexilate LY3314814 + Dabigatran Etexilate
Hide Arm/Group Description Single dose of dabigatran etexilate administered orally on Day 1. Single dose of LY3314814 administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the LY3314814 dosing
Period Title: Period 1
Started 60 0
Received at Least 1 Dose of Study Drug 60 0
Completed 60 0
Not Completed 0 0
Period Title: Period 2
Started 0 [1] 60 [2]
Completed 0 58
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Physician Decision             0             1
[1]
A single oral dose of 150 mg dabigatran etexilate was administered on Day 1 of Period 1.
[2]
Daily doses of 50 mg LY3314814 were administered daily on Days 3 to 21 of Period 2.
Arm/Group Title Overall
Hide Arm/Group Description Overall study population
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
Received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
36.1  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female 8
Male 52
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Hispanic or Latino 12
Not Hispanic or Latino 48
Unknown or Not Reported 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 31
White 25
More than one race 4
Unknown or Not Reported 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran
Hide Description [Not Specified]
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and have evaluable pharmacokinetic (PK) data.
Arm/Group Title Dabigatran Etexilate LY3314814 and Dabigatran Etexilate Day 16 LY3314814 and Dabigatran Etexilate Day 20
Hide Arm/Group Description:
Single dose of 150mg dabigatran etexilate administered orally on Day 1.
Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on day 16.
Single dose of LY3314814 administered orally once daily on Days 3 to 21.Single dose of dabigatran etexilate administered orally 4 hours after LY3314814 administration on Day 20.
Overall Number of Participants Analyzed 60 56 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
128
(69%)
148
(56%)
138
(46%)
2.Primary Outcome
Title Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)
Hide Description [Not Specified]
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title Dabigatran Etexilate LY3314814 and Dabigatran Etexilate Day 16 LY3314814 and Dabigatran Etexilate Day 20
Hide Arm/Group Description:
Single dose of 150mg dabigatran etexilate administered orally on Day 1.
Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on day 16.
Single dose of LY3314814 administered orally once daily on Days 3 to 21.Single dose of dabigatran etexilate administered orally 4 hours after LY3314814 administration on Day 20.
Overall Number of Participants Analyzed 60 56 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
1090
(61%)
1240
(53%)
1110
(44%)
3.Secondary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat
Hide Description [Not Specified]
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received one dose of study drug and had evaluable PK data.
Arm/Group Title LY3314814 (AZD3293) LY3314814 and Dabigatran Etexilate Day 16 LY3314814 and Dabigatran Etexilate Day 20
Hide Arm/Group Description:
50 mg LY3314814 administered orally alone on Day 15.
Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on day 16.
Single dose of LY3314814 administered orally once daily on Days 3 to 21.Single dose of dabigatran etexilate administered orally 4 hours after LY3314814 administration on Day 20.
Overall Number of Participants Analyzed 57 57 56
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
342
(23%)
315
(21%)
331
(21%)
4.Secondary Outcome
Title Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)
Hide Description [Not Specified]
Time Frame Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received one dose of study drug and had evaluable PK data.
Arm/Group Title LY3314814 (AZD3293) LY3314814 and Dabigatran Etexilate Day 16 LY3314814 and Dabigatran Etexilate Day 20
Hide Arm/Group Description:
50 mg LY3314814 administered orally alone on Day 15
Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on Day 16.
Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on day 20.
Overall Number of Participants Analyzed 57 57 56
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
3360
(25%)
3300
(26%)
3490
(24%)
5.Secondary Outcome
Title Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time
Hide Description [Not Specified]
Time Frame Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable Pharmacodynamic (PD) data.
Arm/Group Title Dabigatran Extexilate Day 1 LY3314814 and Dabigatran Etexilate Day 16 LY3314814 and Dabigatran Etexilate Day 20
Hide Arm/Group Description:
Single dose of 150 mg dabigatran etexilate administered orally on Day 1
Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on Day 16.
Single dose of LY3314814 administered orally once daily on Days 3 to 21.Single dose of dabigatran etexilate administered orally 4 hours after LY3314814 administration on Day 20.
Overall Number of Participants Analyzed 57 55 49
Mean (Standard Deviation)
Unit of Measure: seconds*hour (s*h)
2080  (517) 2170  (611) 2030  (518)
6.Secondary Outcome
Title Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time
Hide Description 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
Time Frame Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable Pharmacodynamic (PD) data.
Arm/Group Title Dabigatran Extexilate Day 1 LY3314814 and Dabigatran Etexilate Day 16 LY3314814 and Dabigatran Etexilate Day 20
Hide Arm/Group Description:
Single dose of 150mg dabigatran etexilate administered orally on Day 1.
Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on Day 16.
Single dose of LY3314814 administered orally once daily on Days 3 to 21.Single dose of dabigatran etexilate administered orally 4 hours after LY3314814 administration on Day 20.
Overall Number of Participants Analyzed 42 42 32
Median (Full Range)
Unit of Measure: ratio of maximum effect
7.10
(3.49 to 7.84)
7.09
(1.06 to 7.84)
7.00
(1.10 to 7.95)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate LY3314814 (AZD3293) LY3314814 and Dabigatran Etexilate Day 16 LY3314814 and Dabigatran Etexilate Day 20
Hide Arm/Group Description Single dose of 150mg dabigatran etexilate administered orally. 50 mg LY3314814 administered orally alone on Day 15 Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on Day 16. Single dose of LY3314814 administered orally once daily on Days 3 to 21. Concurrent single dose of dabigatran etexilate administered orally on day 20.
All-Cause Mortality
Dabigatran Etexilate LY3314814 (AZD3293) LY3314814 and Dabigatran Etexilate Day 16 LY3314814 and Dabigatran Etexilate Day 20
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate LY3314814 (AZD3293) LY3314814 and Dabigatran Etexilate Day 16 LY3314814 and Dabigatran Etexilate Day 20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/60 (0.00%)      0/58 (0.00%)      0/58 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dabigatran Etexilate LY3314814 (AZD3293) LY3314814 and Dabigatran Etexilate Day 16 LY3314814 and Dabigatran Etexilate Day 20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/60 (5.00%)      8/60 (13.33%)      2/58 (3.45%)      4/58 (6.90%)    
Gastrointestinal disorders         
Gingival pain  1  0/60 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0 0/58 (0.00%)  0
Nausea  1  0/60 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0 0/58 (0.00%)  0
Vomiting  1  0/60 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0 1/58 (1.72%)  1
General disorders         
Asthenia  1  0/60 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0 0/58 (0.00%)  0
Chest pain  1  0/60 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0 0/58 (0.00%)  0
Fatigue  1  1/60 (1.67%)  1 0/60 (0.00%)  0 0/58 (0.00%)  0 0/58 (0.00%)  0
Feeling hot  1  0/60 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0 0/58 (0.00%)  0
Vessel puncture site haematoma  1  1/60 (1.67%)  1 0/60 (0.00%)  0 0/58 (0.00%)  0 0/58 (0.00%)  0
Vessel puncture site swelling  1  0/60 (0.00%)  0 0/60 (0.00%)  0 1/58 (1.72%)  1 0/58 (0.00%)  0
Infections and infestations         
Upper respiratory tract infection  1  0/60 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0 1/58 (1.72%)  1
Injury, poisoning and procedural complications         
Skin abrasion  1  0/60 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0 1/58 (1.72%)  1
Musculoskeletal and connective tissue disorders         
Back pain  1  1/60 (1.67%)  1 0/60 (0.00%)  0 0/58 (0.00%)  0 0/58 (0.00%)  0
Nervous system disorders         
Dizziness  1  0/60 (0.00%)  0 2/60 (3.33%)  2 1/58 (1.72%)  1 0/58 (0.00%)  0
Headache  1  0/60 (0.00%)  0 3/60 (5.00%)  4 0/58 (0.00%)  0 0/58 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/60 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0 0/58 (0.00%)  0
Haemoptysis  1  0/60 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0 0/58 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis contact  1  0/60 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0 1/58 (1.72%)  1
Rash  1  0/60 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0 1/58 (1.72%)  2
Skin irritation  1  0/60 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0 0/58 (0.00%)  0
Vascular disorders         
Flushing  1  0/60 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0 0/58 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5079
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 Submitted: October 2, 2015
First Posted: October 5, 2015
Results First Submitted: December 13, 2018
Results First Posted: April 5, 2019
Last Update Posted: April 5, 2019