Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) "After Multiple Oral Doses" in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02111330
• Date of registration: 20/03/2014
• Prospective Registration: No
• Primary sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Public title: Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) "After Multiple Oral Doses" in Healthy Volunteers
• Scientific title: Randomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) "After Multiple Oral Doses" in Healthy Volunteers
• Date of first enrolment: March 2014
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02111330
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Spain

Contacts

• Name: Juan Martínez Colomer, MD
• Affiliation: CIM Sant Pau - I.I.B. Sant Pau

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male or females subjects, 18-45 years (inclusive) of age at the time of
enrollment.

- Females must be of non-childbearing potential (i.e., surgically sterile) or have to
use contraceptive measures (non-hormonal) such as condom, diaphragm or cervical/vault
cap with spermicide. Males should agree to abstain from sexual intercourse with a
female partner or agree to use a condom/spermicide, in addition to having their
female partner use some contraceptive measures.

- 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).

- 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.

- Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine
patches, etc., for 6 months prior to the administration of the study medication

- History of alcohol dependence or drug abuse in the last 5 years or daily consumption
of alcohol > 40 g for men or 24 gr/day for women or high consumption of stimulating
beverages (> 5 coffees, teas or coca cola drinks/ day)

- 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.

- Having donated blood during 4 weeks 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 that would interfere with measurement of
the QT interval.

- Symptoms of a significant somatic or mental illness in the four week period preceding
drug administration.

- History of hepatitis HBV and / or HCV and / or positive serology results which
indicate the presence of hepatitis B surface antigen and / or detectable HCV
ribonucleic acid (RNA).

- 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 drugs at screening period or the day before starting
treatment period. A minimum list of drugs that will be screened for include
Amphetamines, Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive
results may be repeated at the discretion of the Principal Investigator).

- Known hypersensitivity to the study drug or the composition of the galenical form.

- History of psychiatric diseases or epileptic seizures

- Females with positive results from the pregnancy test or breast-feeding.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Placebo

Drug: PBF-509

Primary Outcome(s)

Number of Adverse Events [Time Frame: day 0-9]

Secondary Outcome(s)

Pharmacokinetic Profile Analysis (Plasma concentrations) [Time Frame: day 0-9]

Secondary ID(s)

2013-005035-25

IIBSP-PBF-2013-155

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Palo Biofarma, S.L