Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers

Study Overview
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Brief Summary
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Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: RO-14


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers: male subjects aged between 18 and 45 years Body weight: 65-75 Kg Not meaningful abnormalities in physical examination and in clinical history Without evidence of significant organic or psychiatric illness Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months Not give blood in the last 4 weeks. Healthy male volunteers who have not received heparin in the past Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent Exclusion Criteria: Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption Important consumption of exciting drinks: alcohol consumption > 30 g/day; coffee, tea, cola > 5 /day Allergy, idiosyncrasy or hypersensitivity to medicines Healthy volunteers who are receiving another medication in the past 15 days Positive serology of hepatitis B, C or HIV Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events Mayor Surgery in the last 6 months Smoking > 10 cigarettes / day Ethanol, cannabis, cocaine, amphetamine, benzodiazepine or opiate in urine Healthy volunteers with a familiar history evident hemorrhagic episodes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ro-14<br> | Drug: RO-14<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers |  | safety parameters | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses. |  | anti-Xa activity | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, ultra low molecular weight heparin