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:
Information provided by:
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier:
NCT00629733
First received: February 15, 2008
Last updated: June 7, 2011
Last verified: June 2011
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 15, 2008
Last Updated: June 7, 2011
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014