Effects of LMWH in Healthy Subjects Treated With TB-402 and Effects of TB-402 in Healthy Subjects Treated With Warfarin
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects
- Registration Number
- NCT00618579
- Lead Sponsor
- ThromboGenics
- Brief Summary
Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LMWH arm - active LMWH LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects - LMWH arm - placebo LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects - Warfarin arm - active warfarin LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects - Warfarin arm - control LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects -
- Primary Outcome Measures
Name Time Method Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c To study end
- Secondary Outcome Measures
Name Time Method Changes in safety parameters over time, PK parameters estimated by NCA, effect of LMWH in TB-402 treated subjects assessed by anti factor Xa (LMWH arm) To study end
Trial Locations
- Locations (1)
Cyncron CRU
🇩🇰Copenhagen, Denmark