Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-680 After Multiple Oral Doses"

NCT02208973 | Completed Phase 1

• 2 other identifiers: IIBSP-PBF-2014-042014-000425-20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

To assess the safety and tolerability of five doses of PBF-680 (5 mg, 10 mg, 20 mg, 40 mg and 60mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.

Conditions

Asthma

Keywords

Adenosine A1 receptor antagonist; adenosine receptor modulator; Asthma; COPD

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Serious and Non-Serious Adverse Events

  Vital Signs, ECG recordings, laboratory safety test and phisical examination will be performed

  from day 0 to day 15

Secondary Outcomes (1)

• Pharmacokinetic Profile Analysis (Plasma concentrations)

  from day 1 to day 8

Other Outcomes (2)

• Adenosine A1 receptor antagonism activity

  day 1 and day 8

• Leeds Sleep Evaluation Questionnaire

  from day 1 to day 8

Study Arms (6)

PBF-680 (5 mg)

EXPERIMENTAL

5 mg of PBF-680

Drug: PBF-680

PBF-680 (10 mg)

EXPERIMENTAL

10 mg of PBF-680

Drug: PBF-680

PBF-680 (20 mg)

EXPERIMENTAL

20 mg of PBF-680

Drug: PBF-680

PBF-680 (40 mg)

EXPERIMENTAL

40 mg of PBF-680

Drug: PBF-680

PBF-680 (60 mg)

EXPERIMENTAL

60 mg of PBF-680

Drug: PBF-680

Placebo

PLACEBO COMPARATOR

Comparator to the doses of 5, 10, 20, 40 and 60 mg. ( subjects for each dose level 6 are located to active treatment and two to placebo

Drug: Placebo

Interventions

PBF-680 DRUG

5, 10, 20, 40 and 60 mg of PBF-680

PBF-680 (10 mg); PBF-680 (20 mg); PBF-680 (40 mg); PBF-680 (5 mg); PBF-680 (60 mg)

Placebo DRUG

placebo for the dose of 5, 10, 20 and 40 mg of PBF-680

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 until 28 days post-administration. Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide, in addition to having their female partner use some contraceptive measures until 28 days post-administration.
• 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:

• Subjects meeting any of the following criteria at screening visit will be excluded from entry into the study:
• 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) for both sexes.
• 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 absortion, 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, bradychardia (\<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).

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 - IIB Sant Pau, HSCSP

Barcelona, Barcelona, 08025, Spain

Location

Palobiofarma S.L. (molecule owner)

Mataró, Barcelona, 08302, Spain

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joan Martínez Colomer, MD

  CIM Sant Pau - IIB Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 5, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

ES (2)