NCT00629733

CompletedPhase 1

Clinical Trial to Evaluate the Tolerability and Pharmacokine...

Rovi Pharmaceuticals Laboratories Source

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Other study identifiers

Sponsor study identifier

ROV-RO14-2006-01

Study Type

interventional

Estimated enrollment

12

Locations

1 country

Sites

1

Timeline

Study Start

December 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2007

Actual (reported)

Study Completion

December 2008

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 12 participants
Study completion date: December 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2007
Actual (reported)
First Submitted
February 15, 2008
Actual (reported)
First Posted
March 6, 2008
Actual (reported)
Study Completion
December 2008
Actual (reported)

Last Updated: June 8, 2011
Status Verified: June 2011
Last Update Submitted: June 7, 2011

Conditions

Healthy

Keywords

pharmacokineticsultra 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-14Drug

Ro-14

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy volunteers: male subjects aged between 18 and 45 years
Body weight: 65-75 Kg

Sponsors & Collaborators

Rovi Pharmaceuticals Laboratories
Industrylead

Study Sites (1)

Hospital Santa Creu i Sant Pau

Barcelona, Spain

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 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2007

Actual (reported)

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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

Contact the study team to confirm eligibility.

Study Completion

December 2008

Actual (reported)

Last Updated

June 8, 2011

Record last verified: 2011-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00629733
Data provider: ClinicalTrials.gov
Source updated: 2011-06-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:36 UTC

Locations

ES(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Ro-14

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations