This Phase 1 study is planned to establish the clinical safety and pharmacokinetics profile of multiple dose of LT3001 drug product and to investigate drug interactions of LT3001 with potential concomitant medications in healthy subjects.
This study is a two-part study. Part A is double-blind, placebo-controlled, and will examine the safety and PK profiles of multiple doses of LT3001 drug product in healthy subjects. Part B is open-label and will assess the safety and PK of LT3001 when coadministered with aspirin, clopidogrel, apixaban or dabigatran.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Lumosa Phase 1 Unit
Cypress, California, United States
Number of Adverse Events
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.
Time frame: 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.
Change From Baseline in Activated Partial Thromboplastin Time (APTT)
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.
Time frame: 16 days
Number of Participants With Prolongation in Platelet Function Test
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.
Time frame: 16 days
Plasma PK Parameters of LT3001 - Cmax
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Time frame: Predose and post-dose time points up to 10 days after dosing
Plasma PK Parameters of LT3001 - Tmax
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
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Loading and maintenance doses of Clopidogrel administered by oral
Multiple doses of Apixaban administered by oral
Multiple doses of Dabigatran administered by oral
Time frame: 10 days
Plasma PK Parameters of LT3001 - AUC
Plasma concentrations of LT3001 and derived PK parameters up to 10 days after a single dose or multiple doses intravenous infusion of LT3001.
Time frame: 10 days
Plasma PK Parameters of Aspirin - Cmax
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.
Time frame: 8 days
Plasma PK Parameters of Aspirin - Tmax
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.
Time frame: 8 days
Plasma PK Parameters of Aspirin - AUC
Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin were administered.
Time frame: 8 days
Plasma PK Parameters of Clopidogrel - Cmax
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel were administered.
Time frame: 10 days
Plasma PK Parameters of Clopidogrel - Tmax
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).
Time frame: 10 days
Plasma PK Parameters of Clopidogrel - AUC
Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel were administered.
Time frame: 10 days
Plasma PK Parameters of Apixaban - Cmax
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.
Time frame: 8 days
Plasma PK Parameters of Apixaban - Tmax
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.
Time frame: 8 days
Plasma PK Parameters of Apixaban - AUC
Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban were administered.
Time frame: 8 days
Plasma PK Parameters of Dabigatran - Cmax
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran were administered.
Time frame: 8 days
Plasma PK Parameters of Dabigatran - Tmax
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Time frame: 8 days
Plasma PK Parameters of Dabigatran - AUC
Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).
Time frame: 8 days