Effects of LMWH in Healthy Subjects Treated With TB-402 and Effects of TB-402 in Healthy Subjects Treated With Warfarin

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ThromboGenics
• Collaborator: BioInvent International AB
• Treatments: Warfarin

Criteria

Inclusion Criteria include:

• Males 18 to 45 years of age

• Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine

Exclusion Criteria include:

• Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke

• History of important bleeding episodes

• Previous allergic reaction to immunoglobulin

• Present or previous history of severe allergy, for example asthma or anaphylactic reactions

• FVIII:C <50% at screening

• Clinically significant out of range values for any coagulation test during screening

• Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402