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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
February 15, 2008
March 6, 2008
June 8, 2011
December 2007
December 2007   (Final data collection date for primary outcome measure)
Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers [ Time Frame: safety parameters ]
Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers [ Time Frame: 6 ]
Complete list of historical versions of study NCT00629733 on ClinicalTrials.gov Archive Site
Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses. [ Time Frame: anti-Xa activity ]
Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses. [ Time Frame: 6 ]
Not Provided
Not Provided
 
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
Not Provided
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
Drug: RO-14
Experimental: Ro-14
Intervention: Drug: RO-14
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2008
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00629733
ROV-RO14-2006-01
No
Not Provided
Not Provided
Dr. Barbanoj, Hospital Santa Creu i Sant Pau
Rovi Pharmaceuticals Laboratories
Not Provided
Principal Investigator: Dr Manuel Barbanoj Hospital Santa Creu i Sant Pau
Rovi Pharmaceuticals Laboratories
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP