Trial Outcomes & Findings for A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects (NCT NCT04809818)
NCT ID: NCT04809818
Last Updated: 2026-03-02
Results Overview
To evaluate the safety and tolerability of LT3001 administered alone or in combination with aspirin, clopidogrel, apixaban, or dabigatran, as determined by the number and severity of adverse events collected from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
Results posted on
2026-03-02
Participant Flow
Participant milestones
| Measure |
Part A - LT3001 Drug Product
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion according to the study protocol.
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion according to the study protocol.
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 administered by intravenous infusion in combination with oral aspirin administered at loading and maintenance doses according to the study protocol.
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 administered by intravenous infusion in combination with oral Clopidogrel administered at loading and maintenance doses according to the study protocol.
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 administered by intravenous infusion in combination with oral Apixaban administered at loading and maintenance doses according to the study protocol.
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 administered by intravenous infusion in combination with oral Dabigatran administered at loading and maintenance doses according to the study protocol.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
13
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
4
|
12
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
Baseline characteristics by cohort
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
n=4 Participants
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
n=13 Participants
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
n=12 Participants
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
n=12 Participants
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
n=12 Participants
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 year
n=41 Participants
|
43.5 year
n=35 Participants
|
45 year
n=76 Participants
|
42.5 year
n=565 Participants
|
45.5 year
n=196 Participants
|
55 year
n=4 Participants
|
42 year
n=10 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
4 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
13 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
12 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
12 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
12 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
65 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B Cohort 1, but only 12 subjects completed the study.
|
|
Sex: Female, Male
Female
|
7 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
3 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
7 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
6 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
5 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
7 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
35 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
|
Sex: Female, Male
Male
|
5 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
1 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
6 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
6 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
7 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
5 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
30 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
2 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
2 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
1 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
11 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
1 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
5 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
5 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
2 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
3 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
17 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
|
Race (NIH/OMB)
White
|
5 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
1 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
8 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
7 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
6 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
8 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
35 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=35 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=76 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=565 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
2 Participants
n=196 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
0 Participants
n=4 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
2 Participants
n=10 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
|
Region of Enrollment
United States
|
12 participants
n=41 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
4 participants
n=35 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
13 participants
n=76 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
12 participants
n=565 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
12 participants
n=196 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
12 participants
n=4 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
65 participants
n=10 Participants • A total of 13 subjects were enrolled in Part B cohort 1, but only 12 subjects completed the study.
|
PRIMARY outcome
Timeframe: Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.Population: Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
To evaluate the safety and tolerability of LT3001 administered alone or in combination with aspirin, clopidogrel, apixaban, or dabigatran, as determined by the number and severity of adverse events collected from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
n=4 Participants
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
n=12 Participants
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
n=12 Participants
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
n=12 Participants
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
n=12 Participants
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Number of Adverse Events
|
3 event
|
0 event
|
2 event
|
2 event
|
2 event
|
1 event
|
SECONDARY outcome
Timeframe: 16 daysPopulation: Activated Partial Thromboplastin Time
Change from baseline in activated partial thromboplastin time (APTT), measured in seconds, was assessed to evaluate the safety of LT3001 administered alone or in combination with aspirin, clopidogrel, apixaban, or dabigatran from baseline up to 16 days post-dose.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
n=4 Participants
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
n=12 Participants
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
n=12 Participants
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
n=12 Participants
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
n=12 Participants
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Activated Partial Thromboplastin Time (APTT)
|
-0.62 second
Standard Deviation 0.888
|
-0.58 second
Standard Deviation 0.830
|
2.62 second
Standard Deviation 5.576
|
1.75 second
Standard Deviation 3.349
|
0.009 second
Standard Deviation 1.407
|
6.83 second
Standard Deviation 4.003
|
SECONDARY outcome
Timeframe: 16 daysPopulation: Prolongation in collagen/epinephrine or collagen/ADP. Participants in the Part A placebo group did not undergo platelet function testing and were therefore not included in this outcome analysis.
The outcome measured the number of participants with prolongation in platelet function test results following administration of LT3001 alone or in combination with aspirin, clopidogrel, apixaban, or dabigatran. Platelet function was assessed using collagen/epinephrine and collagen/ADP assays. Results were evaluated from baseline up to 16 days post-dose. Participants in the Part A placebo group did not undergo platelet function testing and were therefore not included in this outcome analysis.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
n=12 Participants
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
n=12 Participants
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
n=12 Participants
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
n=12 Participants
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Number of Participants With Prolongation in Platelet Function Test
collagen/epinephrine
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Prolongation in Platelet Function Test
collagen/ADP
|
1 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Predose and post-dose time points up to 10 days after dosingPopulation: The pharmacokinetic analysis population included participants with sufficient plasma concentration data to estimate Cmax. Participants with missing or non-evaluable PK samples were excluded from the analysis.
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
n=11 Participants
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
n=11 Participants
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
n=12 Participants
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
n=12 Participants
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of LT3001 - Cmax
|
48.86 ng/mL
Standard Deviation 17.06
|
45.30 ng/mL
Standard Deviation 12.31
|
43.23 ng/mL
Standard Deviation 9.569
|
42.28 ng/mL
Standard Deviation 15.62
|
43.96 ng/mL
Standard Deviation 12.57
|
—
|
SECONDARY outcome
Timeframe: 10 daysPlasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
n=11 Participants
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
n=11 Participants
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
n=12 Participants
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
n=12 Participants
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of LT3001 - Tmax
|
0.22 hour
Standard Deviation 0.054
|
0.18 hour
Standard Deviation 0.073
|
0.21 hour
Standard Deviation 0.054
|
0.24 hour
Standard Deviation 0.057
|
0.21 hour
Standard Deviation 0.043
|
—
|
SECONDARY outcome
Timeframe: 10 daysPlasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
n=11 Participants
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
n=11 Participants
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
n=12 Participants
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
n=12 Participants
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of LT3001 - AUC
|
11.87 h*ng/mL
Standard Deviation 3.364
|
9.820 h*ng/mL
Standard Deviation 3.002
|
10.21 h*ng/mL
Standard Deviation 2.073
|
10.32 h*ng/mL
Standard Deviation 3.173
|
9.769 h*ng/mL
Standard Deviation 2.558
|
—
|
SECONDARY outcome
Timeframe: 8 daysPlasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=6 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Aspirin - Cmax
|
477 ng/mL
Standard Deviation 362.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 daysPopulation: Participants with Plasma concentrations of Aspirin at Day 5
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=6 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Aspirin - Tmax
|
3.7 hour
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 daysPlasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=6 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Aspirin - AUC
|
1709 h*ng/mL
Standard Deviation 1251
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 daysPlasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel were administered.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Clopidogrel - Cmax
|
3.925 ng/mL
Standard Deviation 1.991
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 daysPlasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Clopidogrel - Tmax
|
2.0 hour
Standard Deviation 1.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 daysPlasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel were administered.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Clopidogrel - AUC
|
8.255 h*ng/mL
Standard Deviation 5.129
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 daysPlasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Apixaban - Cmax
|
188.5 ng/mL
Standard Deviation 76.11
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 daysPlasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Apixaban - Tmax
|
3.1 hour
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 daysPlasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Apixaban - AUC
|
593.8 h*ng/mL
Standard Deviation 26.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 daysPlasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran were administered.
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Dabigatran - Cmax
|
146.1 ng/mL
Standard Deviation 30.77
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 daysPlasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Dabigatran - Tmax
|
4.1 hour
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 daysPlasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Outcome measures
| Measure |
Part A - LT3001 Drug Product
n=12 Participants
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Plasma PK Parameters of Dabigatran - AUC
|
1807 h*ng/mL
Standard Deviation 405.3
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A - LT3001 Drug Product
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B - LT3001 and Aspirin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B - LT3001 and Clopidogrel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B - LT3001 and Apixaban
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B - LT3001 and Dabigatran
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 |
Part A - LT3001 Drug Product
n=12 participants at risk
Multiple doses of LT3001 administered by intravenous infusion
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
|
Part A - Placebo
n=4 participants at risk
Multiple doses of Placebo administered by intravenous infusion
Placebo: Multiple doses of Placebo administered by intravenous infusion
|
Part B - LT3001 and Aspirin
n=12 participants at risk
Multiple doses of LT3001 and Aspirin administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Aspirin: Loading and maintenance doses of Aspirin administered by oral
|
Part B - LT3001 and Clopidogrel
n=12 participants at risk
Multiple doses of LT3001 and Clopidogrel administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Clopidogrel: Loading and maintenance doses of Clopidogrel administered by oral
|
Part B - LT3001 and Apixaban
n=12 participants at risk
Multiple doses of LT3001 and Apixaban administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Apixaban: Multiple doses of Apixaban administered by oral
|
Part B - LT3001 and Dabigatran
n=12 participants at risk
Multiple doses of LT3001 and Dabigatran administered
LT3001 drug product: Multiple doses of LT3001 drug product administered by intravenous infusion
Dabigatran: Multiple doses of Dabigatran administered by oral
|
|---|---|---|---|---|---|---|
|
Endocrine disorders
Menstruation irregular
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
16.7%
2/12 • Number of events 2 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
|
Infections and infestations
Oral herpes
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
16.7%
2/12 • Number of events 2 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/4 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
0.00%
0/12 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
8.3%
1/12 • Number of events 1 • Adverse events were assessed from baseline through Day 4 post-baseline in Part A, and from baseline through Day 16 post-baseline in Part B.
All-cause mortality, serious adverse events, and other (non-serious) adverse events were monitored during the specified adverse event reporting period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place