Trials / Completed
CompletedNCT03652779
A Study to Evaluate the Safety and Tolerability of Tecarfarin in Healthy Chinese Volunteers
An Open-label, Phase 1, Sequential Cohort, Single-Dose Escalation Study to Assess the Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Lee's Pharmaceutical Limited · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to evaluate the safety and tolerability of a single dose of tecarfarin in healthy Chinese Volunteers. the Pharmacokinetic and pharmacodynamic profile of tecarfarin will also be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tecarfarin 10mg | Tecarfarin 10mg tablets |
| DRUG | Tecarfarin 20mg | two tecarfarin 10mg tablets |
| DRUG | Tecarfarin 30mg | three tecarfarin 10mg tablets |
| DRUG | Tecarfarin 40mg | four tecarfarin 10mg tablets |
Timeline
- Start date
- 2018-06-22
- Primary completion
- 2019-10-28
- Completion
- 2019-10-28
- First posted
- 2018-08-29
- Last updated
- 2019-11-21
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT03652779. Inclusion in this directory is not an endorsement.