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

NCT00629733 | Completed Phase 1

• 1 other identifier: ROV-RO14-2006-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

pharmacokinetics; ultra low molecular weight heparin

Outcome Measures

Primary Outcomes (1)

• Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers

  safety parameters

Secondary Outcomes (1)

• Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses.

  anti-Xa activity

Study Arms (1)

Ro-14

EXPERIMENTAL

Drug: RO-14

Interventions

RO-14 DRUG

Ro-14

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rovi Pharmaceuticals Laboratories: lead

Study Sites (1)

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Location

Study Officials

• Dr Manuel Barbanoj

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: March 6, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

ES (1)