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Trial record 27 of 733 for:    warfarin

A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02540668
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Lanabecestat
Drug: Warfarin
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Warfarin LY3314814 + Warfarin
Hide Arm/Group Description Single oral dose of 15 milligram (mg) warfarin on Day 1. LY3314814 administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.
Period Title: Period 1 - Warfarin Single Dose
Started 15 0
Received at Least One Dose of Study Drug 15 0
Completed 15 0
Not Completed 0 0
Period Title: Period 2 - LY3314814 and Warfarin
Started 0 [1] 15 [2]
Completed 0 14
Not Completed 0 1
Reason Not Completed
Physician Decision             0             1
[1]
Warfarin was administered alone only in Period 1.
[2]
Warfarin was co-administered with LY3314814 only in Period 2.
Arm/Group Title Overall
Hide Arm/Group Description Overall study population.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Participants who received one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
42.9  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
0
   0.0%
Male
15
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
1
   6.7%
Not Hispanic or Latino
14
  93.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  33.3%
White
9
  60.0%
More than one race
1
   6.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
1.Primary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin
Hide Description [Not Specified]
Time Frame Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Warfarin LY3314814 + Warfarin
Hide Arm/Group Description:

Single oral dose of 15 mg warfarin on Day 1.

Warfarin: Administered orally

LY3314814 administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.

LY3314814: Administered orally

Warfarin: Administered orally

Overall Number of Participants Analyzed 15 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
3.50
(12%)
3.73
(14%)
2.Primary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin
Hide Description [Not Specified]
Time Frame Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Warfarin LY3314814 + Warfarin
Hide Arm/Group Description:

Single oral dose of 15 mg warfarin on Day 1.

Warfarin: Administered orally

LY3314814 administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.

LY3314814: Administered orally

Warfarin: Administered orally

Overall Number of Participants Analyzed 15 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram * hour per milliliter(ng*h/mL)
108
(18%)
123
(19%)
3.Secondary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin
Hide Description [Not Specified]
Time Frame Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Warfarin LY3314814 + Warfarin
Hide Arm/Group Description:

Single oral dose of 15 mg warfarin on Day 1.

Warfarin: Administered orally

LY3314814 administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.

LY3314814: Administered orally

Warfarin: Administered orally

Overall Number of Participants Analyzed 15 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
4.45
(11%)
4.80
(14%)
4.Secondary Outcome
Title Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin
Hide Description [Not Specified]
Time Frame Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96,120, and 144 hours after administration of warfarin on Days 1 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Warfarin LY3314814 + Warfarin
Hide Arm/Group Description:

Single oral dose of 15 mg warfarin on Day 1.

Warfarin: Administered orally

LY3314814 administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.

LY3314814: Administered orally

Warfarin: Administered orally

Overall Number of Participants Analyzed 15 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
262
(18%)
296
(18%)
5.Secondary Outcome
Title Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin
Hide Description [Not Specified]
Time Frame Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable pharmacodynamic INR data on Day 22 of Period 2.
Arm/Group Title Warfarin LY3314814 + Warfarin
Hide Arm/Group Description:

Single oral dose of 15 mg warfarin on Day 1.

Warfarin: Administered orally

LY3314814 administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.

LY3314814: Administered orally

Warfarin: Administered orally

Overall Number of Participants Analyzed 15 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
160
(9%)
158
(6%)
6.Secondary Outcome
Title Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin
Hide Description [Not Specified]
Time Frame Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable pharmacodynamic INR data on Day 22 of Period 2.
Arm/Group Title Warfarin LY3314814 + Warfarin
Hide Arm/Group Description:

Single oral dose of 15 mg warfarin on Day 1.

Warfarin: Administered orally

LY3314814 administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.

LY3314814: Administered orally

Warfarin: Administered orally

Overall Number of Participants Analyzed 15 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1.29
(18%)
1.26
(12%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Warfarin LY3314814 LY3314814 + Warfarin
Hide Arm/Group Description

Single oral dose of 15 mg warfarin on Day 1.

Warfarin: Administered orally

LY3314814 administered orally once daily on Days 8 to 27

LY3314814: Administered orally

Single oral dose of 15 mg warfarin co-administered on Day 22.

LY3314814: Administered orally

Warfarin: Administered orally

All-Cause Mortality
Warfarin LY3314814 LY3314814 + Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Warfarin LY3314814 LY3314814 + Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Warfarin LY3314814 LY3314814 + Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      1/15 (6.67%)      1/15 (6.67%)    
Eye disorders       
Retinal haemorrhage  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Gastrointestinal disorders       
Abdominal pain upper  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (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: NCT02540668     History of Changes
Other Study ID Numbers: 16008
I8D-MC-AZEO ( Other Identifier: Eli Lilly and Company )
First Submitted: September 2, 2015
First Posted: September 4, 2015
Results First Submitted: December 13, 2018
Results First Posted: March 25, 2019
Last Update Posted: March 25, 2019