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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: RO-14

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ro-14	Drug: RO-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers	safety parameters

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses.	anti-Xa activity

Collaborators and Investigators

• Sponsor: Rovi Pharmaceuticals Laboratories
• Investigators: Principal Investigator: Dr Manuel Barbanoj, Hospital Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): December 1, 2007
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: February 15, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (ESTIMATE): March 6, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 7, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: pharmacokinetics; ultra low molecular weight heparin
• Other Study ID Numbers: ROV-RO14-2006-01