Phase 1
Completed N=65
A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects
Source: ClinicalTrials.gov NCT04809818 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Number of Adverse Events — 3; 0; 2; 2 event
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
3; 0; 2; 2; 2; 1 | — |
| SECONDARY Change From Baseline in Activated Partial Thromboplastin Time (APTT) |
-0.62; -0.58; 2.62; 1.75; 0.009; 6.83 | — |
| SECONDARY Number of Participants With Prolongation in Platelet Function Test |
0; 1; 1; 0; 0; 1 | — |
| SECONDARY Plasma PK Parameters of LT3001 - Cmax |
48.86; 45.30; 43.23; 42.28; 43.96 | — |
| SECONDARY Plasma PK Parameters of LT3001 - Tmax |
0.22; 0.18; 0.21; 0.24; 0.21 | — |
| SECONDARY Plasma PK Parameters of LT3001 - AUC |
11.87; 9.820; 10.21; 10.32; 9.769 | — |
| SECONDARY Plasma PK Parameters of Aspirin - Cmax |
477 | — |
| SECONDARY Plasma PK Parameters of Aspirin - Tmax |
3.7 | — |
| SECONDARY Plasma PK Parameters of Aspirin - AUC |
1709 | — |
| SECONDARY Plasma PK Parameters of Clopidogrel - Cmax |
3.925 | — |
| SECONDARY Plasma PK Parameters of Clopidogrel - Tmax |
2.0 | — |
| SECONDARY Plasma PK Parameters of Clopidogrel - AUC |
8.255 | — |
| SECONDARY Plasma PK Parameters of Apixaban - Cmax |
188.5 | — |
| SECONDARY Plasma PK Parameters of Apixaban - Tmax |
3.1 | — |
| SECONDARY Plasma PK Parameters of Apixaban - AUC |
593.8 | — |
| SECONDARY Plasma PK Parameters of Dabigatran - Cmax |
146.1 | — |
| SECONDARY Plasma PK Parameters of Dabigatran - Tmax |
4.1 | — |
| SECONDARY Plasma PK Parameters of Dabigatran - AUC |
1807 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04809818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.