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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00629733
First Posted: March 6, 2008
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rovi Pharmaceuticals Laboratories
  Purpose
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

Condition Intervention Phase
Healthy Drug: RO-14 Phase 1

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

Resource links provided by NLM:


Further study details as provided by Rovi Pharmaceuticals Laboratories:

Primary Outcome Measures:
  • Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers [ Time Frame: safety parameters ]

Secondary Outcome Measures:
  • Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses. [ Time Frame: anti-Xa activity ]

Estimated Enrollment: 12
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ro-14 Drug: RO-14

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy volunteers: male subjects aged between 18 and 45 years
  2. Body weight: 65-75 Kg
  3. Not meaningful abnormalities in physical examination and in clinical history
  4. Without evidence of significant organic or psychiatric illness
  5. Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
  6. Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range
  7. Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
  8. Not give blood in the last 4 weeks.
  9. Healthy male volunteers who have not received heparin in the past
  10. Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent

Exclusion Criteria:

  1. Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
  2. Important consumption of exciting drinks: alcohol consumption > 30 g/day; coffee, tea, cola > 5 /day
  3. Allergy, idiosyncrasy or hypersensitivity to medicines
  4. Healthy volunteers who are receiving another medication in the past 15 days
  5. Positive serology of hepatitis B, C or HIV
  6. Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events
  7. Mayor Surgery in the last 6 months
  8. Smoking > 10 cigarettes / day
  9. Ethanol, cannabis, cocaine, amphetamine, benzodiazepine or opiate in urine
  10. Healthy volunteers with a familiar history evident hemorrhagic episodes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629733


Locations
Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Sponsors and Collaborators
Rovi Pharmaceuticals Laboratories
Investigators
Principal Investigator: Dr Manuel Barbanoj Hospital Santa Creu i Sant Pau
  More Information

Responsible Party: Dr. Barbanoj, Hospital Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT00629733     History of Changes
Other Study ID Numbers: ROV-RO14-2006-01
First Submitted: February 15, 2008
First Posted: March 6, 2008
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Rovi Pharmaceuticals Laboratories:
pharmacokinetics
ultra low molecular weight heparin

Additional relevant MeSH terms:
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action