Clinical trial NCT04809818: A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects
Official title: Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LT3001 Drug Product and Drug-Drug Interaction in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Ischemic Stroke
Lead sponsor: Lumosa Therapeutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part A: parallel Part B: single group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subject's body weight is ≥50 kg and BMI is within the range of 18 to 32
* Subject is a healthy volunteer.
* Subject's PT, aPTT, and TT are within the normal laboratory range.
* Subject is a nonsmoker

Exclusion Criteria:

* Subject has a current or recent history of regular alcohol consumption.
* Subjects who are enrolled in Part B and allergic to acetylsalicylic acid, other salicylates, clopidogrel, thienopyridines (eg, ticlopidine, prasugrel), apixaban or dabigatran.
* Part B Cohort 2 only: subjects who are poor metabolizers of clopidogrel (CYP2C19\*2/\*2, \*2/\*3, or \*3/\*3 genotype)
* Subject has a presence or history of coagulation abnormality.
* Subjects need to receive a surgery or clinical procedures associated with high bleeding risk.
* Subject has a history of minor bleeding episodes, eg, epistaxis, rectal bleeding, gingival bleeding.
* Subject has a history of peptic ulcer or gastrointestinal bleeding.

Primary outcomes:
measure: Number of adverse events
timeFrame: 16 days
Secondary outcomes:
measure: Changes from baseline in coagulation
timeFrame: 16 days
measure: Changes from baseline in platelet function test
timeFrame: 16 days
measure: Plasma PK parameters of LT3001 - Cmax
timeFrame: 10 days
measure: Plasma PK parameters of LT3001 - Tmax
timeFrame: 10 days
measure: Plasma PK parameters of LT3001 - AUC
timeFrame: 10 days
measure: Plasma PK parameters of Aspirin - Cmax
timeFrame: 8 days
measure: Plasma PK parameters of Aspirin - Tmax
timeFrame: 8 days
measure: Plasma PK parameters of Aspirin - AUC
timeFrame: 8 days
measure: Plasma PK parameters of Clopidogrel - Cmax
timeFrame: 10 days
measure: Plasma PK parameters of Clopidogrel - Tmax
timeFrame: 10 days
measure: Plasma PK parameters of Clopidogrel - AUC
timeFrame: 10 days
measure: Plasma PK parameters of Apixaban - Cmax
timeFrame: 8 days
measure: Plasma PK parameters of Apixaban - Tmax
timeFrame: 8 days
measure: Plasma PK parameters of Apixaban - AUC
timeFrame: 8 days
measure: Plasma PK parameters of Dabigatran - Cmax
timeFrame: 8 days
measure: Plasma PK parameters of Dabigatran - Tmax
timeFrame: 8 days
measure: Plasma PK parameters of Dabigatran - AUC
timeFrame: 8 days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Lumosa Phase 1 Unit
state: California
Study officials:
affiliation: Lumosa Phase 1 unit
name: Mimi Yeh, PhD
role: STUDY_DIRECTOR
References: