- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02208934
Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers
March 7, 2016 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08025
- CIM-Sant Pau - IIB Sant Pau, HSCSP
-
-
Barcelona
-
Mataró, Barcelona, Spain, 08302
- Palobiofarma S.L. (molecule owner)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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).
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 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 6 drugs will be screened for inclusion: 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PBF-999 (5 mg)
5 mg of PBF-999
|
5, 10, 20 and 40 mg of PBF-999
|
Experimental: PBF-999 (10 mg)
10 mg of PBF-999
|
5, 10, 20 and 40 mg of PBF-999
|
Experimental: PBF-999 (20 mg)
20 mg of PBF-999
|
5, 10, 20 and 40 mg of PBF-999
|
Experimental: PBF-999 (40 mg)
40 mg of PBF-999
|
5, 10, 20 and 40 mg of PBF-999
|
Placebo Comparator: Placebo
Placebo for the 5, 10, 20 and 40 mg dose
|
Placebo for all dosis of PBF-999
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: day 0 to day 7
|
Vital Signs, ECG recordings, laboratory safety test and physical examination will be performed
|
day 0 to day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic Profile Analysis (Plasma concentrations)
Time Frame: day 1
|
Baseline [pre-dose], [+ 10 min], [+ 20 min], [+ 40 min], [+ 60 min], [+ 1.5h], [+ 2 h], [+ 2.5 h], [+ 3 h], [+ 4h], [+ 8h], [+ 12h], [+16h] and [+ 24h] post-medication
|
day 1
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time Frame: baseline and +24h
|
baseline and +24h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joan Martínez Colomer, MD, CIM Sant Pau - IIB Sant Pau
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
August 4, 2014
First Submitted That Met QC Criteria
August 4, 2014
First Posted (Estimate)
August 5, 2014
Study Record Updates
Last Update Posted (Estimate)
March 8, 2016
Last Update Submitted That Met QC Criteria
March 7, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Dementia
- Cognition Disorders
- Chorea
- Huntington Disease
Other Study ID Numbers
- IIBSP-PBF-2014-28
- 2014-002138-29 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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