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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691924
• Other study ID #: IIBSP-PBF-2012-38
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2012
• Last updated: March 7, 2016
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• PBF-509

• Placebo

Locations

Country	Name	City	State
Spain	Cim- Sant Pau, HSCSP	Barcelona	Catalunya/Barcelona
Spain	Palobiofarma S.L. (molecule owner)	Mataró	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Palo Biofarma, S.L

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	Safety and Tolerability evaluation	5-7 days post-dose	Yes
Secondary	Pharmacokinetic profile analysis	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.	0-24 h post dose	No