Trial Outcomes & Findings for A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants (NCT NCT02540668)
NCT ID: NCT02540668
Last Updated: 2019-11-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
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
Results posted on
2019-11-04
Participant Flow
Participant milestones
| Measure |
Warfarin
Single oral dose of 15 milligram (mg) warfarin on Day 1.
|
LY3314814 + Warfarin
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 1 - Warfarin Single Dose
STARTED
|
15
|
0
|
|
Period 1 - Warfarin Single Dose
Received at Least One Dose of Study Drug
|
15
|
0
|
|
Period 1 - Warfarin Single Dose
COMPLETED
|
15
|
0
|
|
Period 1 - Warfarin Single Dose
NOT COMPLETED
|
0
|
0
|
|
Period 2 - LY3314814 and Warfarin
STARTED
|
0
|
15
|
|
Period 2 - LY3314814 and Warfarin
COMPLETED
|
0
|
14
|
|
Period 2 - LY3314814 and Warfarin
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Warfarin
Single oral dose of 15 milligram (mg) warfarin on Day 1.
|
LY3314814 + Warfarin
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 2 - LY3314814 and Warfarin
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall
n=15 Participants
Overall study population.
|
|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 22Population: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
Warfarin
n=15 Participants
Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally
|
LY3314814 + Warfarin
n=15 Participants
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
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin
|
3.50 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 12
|
3.73 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 14
|
PRIMARY outcome
Timeframe: 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 22Population: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
Warfarin
n=15 Participants
Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally
|
LY3314814 + Warfarin
n=15 Participants
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
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin
|
108 nanogram * hour per milliliter(ng*h/mL)
Geometric Coefficient of Variation 18
|
123 nanogram * hour per milliliter(ng*h/mL)
Geometric Coefficient of Variation 19
|
SECONDARY outcome
Timeframe: 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 22Population: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
Warfarin
n=15 Participants
Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally
|
LY3314814 + Warfarin
n=15 Participants
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
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin
|
4.45 ng/mL
Geometric Coefficient of Variation 11
|
4.80 ng/mL
Geometric Coefficient of Variation 14
|
SECONDARY outcome
Timeframe: 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 22Population: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
Warfarin
n=15 Participants
Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally
|
LY3314814 + Warfarin
n=15 Participants
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
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin
|
262 ng*h/mL
Geometric Coefficient of Variation 18
|
296 ng*h/mL
Geometric Coefficient of Variation 18
|
SECONDARY outcome
Timeframe: Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22Population: All participants who received at least one dose of study drug and had evaluable pharmacodynamic INR data on Day 22 of Period 2.
Outcome measures
| Measure |
Warfarin
n=15 Participants
Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally
|
LY3314814 + Warfarin
n=14 Participants
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
|
|---|---|---|
|
Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin
|
160 ng*h/mL
Geometric Coefficient of Variation 9
|
158 ng*h/mL
Geometric Coefficient of Variation 6
|
SECONDARY outcome
Timeframe: Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22Population: All participants who received at least one dose of study drug and had evaluable pharmacodynamic INR data on Day 22 of Period 2.
Outcome measures
| Measure |
Warfarin
n=15 Participants
Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally
|
LY3314814 + Warfarin
n=14 Participants
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
|
|---|---|---|
|
Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin
|
1.29 ng/mL
Geometric Coefficient of Variation 18
|
1.26 ng/mL
Geometric Coefficient of Variation 12
|
Adverse Events
Warfarin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY3314814
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY3314814 + Warfarin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Warfarin
n=15 participants at risk
Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally
|
LY3314814
n=15 participants at risk
LY3314814 administered orally once daily on Days 8 to 27 LY3314814: Administered orally
|
LY3314814 + Warfarin
n=15 participants at risk
Single oral dose of 15 mg warfarin co-administered on Day 22. LY3314814: Administered orally Warfarin: Administered orally
|
|---|---|---|---|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/15
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5079
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60