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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LMWH arm - active LMWH

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

LMWH arm - placebo

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

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

Warfarin arm - active warfarin

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Warfarin arm - control

Group Type OTHER

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes