Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers
2 other identifiers
interventional
32
1 country
2
Brief Summary
Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg, 10 mg, 20 mg and 40 mg ) in Healthy Young Male Volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMarch 8, 2016
March 1, 2016
1.1 years
August 4, 2014
March 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Serious and Non-Serious Adverse Events
Vital Signs, ECG recordings, laboratory safety test and physical examination will be performed
day 0 to day 7
Secondary Outcomes (1)
Pharmacokinetic Profile Analysis (Plasma concentrations)
day 1
Other Outcomes (1)
Leeds Sleep Evaluation Questionnaire (LSEQ)
baseline and +24h
Study Arms (5)
PBF-999 (5 mg)
EXPERIMENTAL5 mg of PBF-999
PBF-999 (10 mg)
EXPERIMENTAL10 mg of PBF-999
PBF-999 (20 mg)
EXPERIMENTAL20 mg of PBF-999
PBF-999 (40 mg)
EXPERIMENTAL40 mg of PBF-999
Placebo
PLACEBO COMPARATORPlacebo for the 5, 10, 20 and 40 mg dose
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects, 18-45 years (inclusive) of age at the time of enrollment.
- 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:
- 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 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CIM-Sant Pau - IIB Sant Pau, HSCSP
Barcelona, Barcelona, 08025, Spain
Palobiofarma S.L. (molecule owner)
Mataró, Barcelona, 08302, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan Martínez Colomer, MD
CIM Sant Pau - IIB Sant Pau
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
September 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 8, 2016
Record last verified: 2016-03