A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04809818
• Other study ID #: LT3001-105
• Status: Recruiting
• Phase: Phase 1
• Start date: March 21, 2021
• Est. completion date: October 19, 2021

Study information

• Verified date: March 2021
• Source: Lumosa Therapeutics Co., Ltd.
• Contact: Kevin Hsiao
• Phone: +886226557918
• Email: kevin_hsiao[@]lumosa.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 19, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke

Intervention

Drug:
• LT3001 drug product
Multiple doses of LT3001 drug product administered by intravenous infusion
• Placebo
Multiple doses of Placebo administered by intravenous infusion
• Aspirin
Loading and maintenance doses of Aspirin administered by oral
• Clopidogrel
Loading and maintenance doses of Clopidogrel administered by oral
• Apixaban
Multiple doses of Apixaban administered by oral
• Dabigatran
Multiple doses of Dabigatran administered by oral

Locations

Country	Name	City	State
United States	Lumosa Phase 1 Unit	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Lumosa Therapeutics Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	To evaluate the safety and tolerability of LT3001 administered alone or with Aspirin, Clopidogrel, Apixaban, Dabigatran determined by number and severity of adverse events from the time of dosing up to 16 days post-dose.	16 days
Secondary	Changes from baseline in coagulation	To evaluate the safety of LT3001 administered alone or with Aspirin, Clopidogrel, Apixaban, Dabigatran determined by coagulation test from baseline up to 16 days post-dose.	16 days
Secondary	Changes from baseline in platelet function test	To evaluate the safety of LT3001 administered alone or with Aspirin, Clopidogrel, Apixaban, Dabigatran determined by platelet function from baseline up to 16 days post-dose.	16 days
Secondary	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.	10 days
Secondary	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.	10 days
Secondary	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.	10 days
Secondary	Plasma PK parameters of Aspirin - Cmax	Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin administered (alone or with LT3001).	8 days
Secondary	Plasma PK parameters of Aspirin - Tmax	Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin administered (alone or with LT3001).	8 days
Secondary	Plasma PK parameters of Aspirin - AUC	Plasma concentrations of Aspirin and derived PK parameters up to 8 days after multiple doses of Aspirin administered (alone or with LT3001).	8 days
Secondary	Plasma PK parameters of Clopidogrel - Cmax	Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).	10 days
Secondary	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).	10 days
Secondary	Plasma PK parameters of Clopidogrel - AUC	Plasma concentrations of Clopidogrel and derived PK parameters up to 10 days after multiple doses of Clopidogrel administered (alone or with LT3001).	10 days
Secondary	Plasma PK parameters of Apixaban - Cmax	Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban administered (alone or with LT3001).	8 days
Secondary	Plasma PK parameters of Apixaban - Tmax	Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban administered (alone or with LT3001).	8 days
Secondary	Plasma PK parameters of Apixaban - AUC	Plasma concentrations of Apixaban and derived PK parameters up to 8 days after multiple doses of Apixaban administered (alone or with LT3001).	8 days
Secondary	Plasma PK parameters of Dabigatran - Cmax	Plasma concentrations of Dabigatran and derived PK parameters up to 8 days after multiple doses of Dabigatran administered (alone or with LT3001).	8 days
Secondary	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).	8 days
Secondary	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).	8 days