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COMPLETEDPHASE1

Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers

Randomized, Double Blind, Placebo Controlled "First In-human" Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-509 in Male Healthy Volunteers

NCT01691924•Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

View on ClinicalTrials.gov

Summary

No clinical trials with PBF-509 in humans have been performed to date. Only preclinical studies have been done to assess the pharmacology and pharmacokinetics, the safety and the toxicological profile of the PBF-509. An initial testing of PBF-509 in humans is planned, starting with the first-into-man clinical trial where a single oral, dose-escalating, and placebo-controlled design will be implemented.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male subjects, 18-45 years of age.
•Clinically acceptable blood pressure and pulse rate in supine and standing position. Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
•Body weight within normal range (Quetelet's index between 19 and 26) expressed as weight (kg) / height (m2)..
•Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication).
•Able to understand the nature of the study and comply with all their requirements.
•Free acceptance to participate in the study by obtains signed informed consent form approved by the Ethics Committee of the Hospital (CEIC).

Exclusion Criteria

•History of serious adverse reactions or hypersensitivity to any drug.
•Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
•Background or clinical evidence of chronic diseases.
•Acute illness two weeks before drug administration.
•Having undergone major surgery during the previous 6 months.
•History of alcohol or drug abuse in the last 5 years.
•Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
•Need of any prescription medication within 14 days prior to the administration of the drug and non prescription medication or herbal medicines within 7 days prior to the administration of the drug.
•Participation in other clinical trials during the previous 90 days in which an investigational drug or a commercially available drug was tested.
•Not having donated blood during 3 month period before inclusion in the study.
+9 more criteria

Locations (2)

Palobiofarma S.L. (molecule owner)

Mataró, Barcelona, Spain

Cim- Sant Pau, HSCSP

Barcelona, Catalunya/Barcelona, Spain

Key Dates

Start Date

October 1, 2012

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

March 8, 2016

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

PBF-509

DRUG

Placebo

DRUG

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

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Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients