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

ThromboGenics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects

Study type: Interventional

Funder types: Industry

Identifiers

NCT00618579

TB-402-003

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

15 participants in 4 patient groups, including a placebo group

LMWH arm - active LMWH

Experimental group

Treatment:

Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects

LMWH arm - placebo

Placebo Comparator group

Treatment:

Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects

Warfarin arm - active warfarin

Experimental group

Treatment:

Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects

Warfarin arm - control

Other group

Treatment:

Drug: LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects