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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01691924
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : March 8, 2016
Palo Biofarma, S.L
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: PBF-509 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsules: solid microcrystalline cellulose c.s.p
Drug: Placebo
Experimental: PBF-509
The initial dose-escalation scheme includes the following eight doses: 10 mg, 20 mg, 40 mg,80 mg, 160 mg, 320 mg, 480 mg and 620 mg. This dose-escalation scheme has been built with the aim to reach the Minimum Intolerated Dose (MID), i.e. when investigator should stop escalating, and consequently the MTD.
Drug: PBF-509

Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 5-7 days post-dose ]
    Safety and Tolerability evaluation

Secondary Outcome Measures :
  1. Pharmacokinetic profile analysis [ Time Frame: 0-24 h post dose ]
    pre-dose; 10; 20; 30; 40; 50; 60; 75 minutes; 1.5h; 2; 2.5; 3; 3.5; 4; 8; 12; 16; 24 hours postdose administration and after recording vital signs.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Each subject must meet all of the following inclusion criteria at the pre-study screening visit (within 4 weeks prior to dosing) in order to participate in this study.
  • 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.
  • Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
  • 12 lead ECG obtained at screening with PR > 220 msec, QRS>120 msec and QTc >440 msec, bradycardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG.
  • Symptoms of a significant somatic or mental illness in the four week period preceding drug administration.
  • History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
  • Positive results from the HIV serology.
  • Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation.
  • Positive results of the drug screening the day before starting treatment period.
  • Known hypersensitivity to the study drug or the composition of the galenical form
  • History of psychiatric diseases or epileptic seizures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01691924

Palobiofarma S.L. (molecule owner)
Mataró, Barcelona, Spain, 08302
Cim- Sant Pau, HSCSP
Barcelona, Catalunya/Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Palo Biofarma, S.L
Principal Investigator: Rosa M. Antonijoan, MD Centre de Investigació de Medicaments. Hospital de la Santa Creu i Sant Pau

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Identifier: NCT01691924     History of Changes
Other Study ID Numbers: IIBSP-PBF-2012-38
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Adenosine A2a receptor antagonist
adenosine receptor modulator

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action