Status:
COMPLETED
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
Lead Sponsor:
Rovi Pharmaceuticals Laboratories
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00629733
Start Date
December 1 2007
End Date
December 1 2008
Last Update
June 8 2011
Active Locations (1)
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1
Hospital Santa Creu i Sant Pau
Barcelona, Spain