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

NCT02111330 | Completed Phase 1

• 2 other identifiers: IIBSP-PBF-2013-1552013-005035-25
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

Study to assess the safety and tolerability of three doses of PBF-509 (80 mg, 160 mg and 240 mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.

Conditions

Parkinson Disease

Keywords

Adenosine A2a receptor antagonist; adenosine receptor modulator; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  day 0-9

Secondary Outcomes (1)

• Pharmacokinetic Profile Analysis (Plasma concentrations)

  day 0-9

Study Arms (6)

Dose I - 80 mg PBF-509

EXPERIMENTAL

one 80 mg PBF-509 capsule

Drug: PBF-509

Dose I - Placebo

PLACEBO COMPARATOR

one Placebo capsule

Drug: Placebo

Dose II - 160 mg PBF-509

EXPERIMENTAL

Two 80 mg PBF-509 capsule

Drug: PBF-509

Dose II - Placebo

PLACEBO COMPARATOR

Two Placebo capsule

Drug: Placebo

Dose III - 240 mg PBF-509

EXPERIMENTAL

three 80 mg PBF-509 capsule

Drug: PBF-509

Dose III - Placebo

PLACEBO COMPARATOR

Three Placebo capsule

Drug: Placebo

Interventions

PBF-509 DRUG

Dose I - 80 mg PBF-509; Dose II - 160 mg PBF-509; Dose III - 240 mg PBF-509

Placebo DRUG

Dose I - Placebo; Dose II - Placebo; Dose III - Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Palo Biofarma, S.L: collaborator

Study Sites (2)

CIM Sant Pau - I.I.B. Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Palobiofarma S.L. (molecule owner)

Mataró, Barcelona, 08302, Spain

Location

MeSH Terms

Conditions

Parkinson Disease; Neoplasms

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Juan Martínez Colomer, MD

  CIM Sant Pau - I.I.B. Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: April 11, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

ES (2)