Parkinson DiseasePhase 1NCT01691924
Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers
A Phase 1 study testing PBF-509 in people with Parkinson Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial summary
No clinical trials with PBF-509 in humans have been performed to date. Only preclinical studies have been done to assess the pharmacology and pharmacokinetics, the safety and the toxicological profile of the PBF-509. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- PBF-509
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2012to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each subject must meet all of the following inclusion criteria at the pre-study screening visit (within 4 weeks prior to dosing) in order to participate in this study.
- Healthy male subjects, 18-45 years of age.
- 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)..
- Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication).
- 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).
Who cannot join
- 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.
- History of alcohol or drug abuse in the last 5 years.
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- 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.
- Not having donated blood during 3 month 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.
- Symptoms of a significant somatic or mental illness in the four week period preceding drug administration.
- History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
- 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 drug screening the day before starting treatment period.
- Known hypersensitivity to the study drug or the composition of the galenical form
- History of psychiatric diseases or epileptic seizures
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Cim- Sant Pau, HSCSP
Barcelona, Catalunya/Barcelona, 08025
Palobiofarma S.L. (molecule owner)
Mataró, Barcelona, 08302
About this study
Official title: Randomized, Double Blind, Placebo Controlled "First In-human" Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-509 in Male Healthy Volunteers
No clinical trials with PBF-509 in humans have been performed to date. Only preclinical studies have been done to assess the pharmacology and pharmacokinetics, the safety and the toxicological profile of the PBF-509.
An initial testing of PBF-509 in humans is planned, starting with the first-into-man clinical trial where a single oral, dose-escalating, and placebo-controlled design will be implemented.
- Conditions
- Parkinson Disease
- Being tested
- PBF-509, Placebo
- Keywords
- Adenosine A2a receptor antagonist, adenosine receptor modulator, Cancer
- Medical subject headings
- Parkinson Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBF-509Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsules: solid microcrystalline cellulose c.s.p Receives: Drug: Placebo |
| PBF-509 | Experimental | The initial dose-escalation scheme includes the following eight doses: 10 mg, 20 mg, 40 mg,80 mg, 160 mg, 320 mg, 480 mg and 620 mg. This dose-escalation scheme has been built with the aim to reach the Minimum Intolerated Dose (MID), i.e. when investigator should stop escalating, and consequently the MTD. Receives: Drug: PBF-509 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Safety and Tolerability evaluation
Measured: 5-7 days post-dose
Secondary outcomes (1)
Pharmacokinetic profile analysis
pre-dose; 10; 20; 30; 40; 50; 60; 75 minutes; 1.5h; 2; 2.5; 3; 3.5; 4; 8; 12; 16; 24 hours postdose administration and after recording vital signs.
Measured: 0-24 h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Palo Biofarma, S.L
- Responsible party
- Sponsor
- Investigators
- Rosa M. Antonijoan, MD, Principal investigator, Centre de Investigació de Medicaments. Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691924
- Sponsor's protocol ID
- IIBSP-PBF-2012-38
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2012
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled "First In-human" Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-509 in Male Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01691924
- Acronym / sponsor ID
- IIBSP-PBF-2012-38
- Conditions
- Parkinson Disease
- Keywords
- Adenosine A2a receptor antagonist, adenosine receptor modulator, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Palo Biofarma, S.L
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
No clinical trials with PBF-509 in humans have been performed to date. Only preclinical studies have been done to assess the pharmacology and pharmacokinetics, the safety and the toxicological profile of the PBF-509.
An initial testing of PBF-509 in humans is planned, starting with the first-into-man clinical trial where a single oral, dose-escalating, and placebo-controlled design will be implemented.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules: solid microcrystalline cellulose c.s.p |
| PBF-509 | Experimental | Drug: PBF-509The initial dose-escalation scheme includes the following eight doses: 10 mg, 20 mg, 40 mg,80 mg, 160 mg, 320 mg, 480 mg and 620 mg. This dose-escalation scheme has been built with the aim to reach the Minimum Intolerated Dose (MID), i.e. when investigator should stop escalating, and consequently the MTD. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Each subject must meet all of the following inclusion criteria at the pre-study screening visit (within 4 weeks prior to dosing) in order to participate in this study.
- Healthy male subjects, 18-45 years of age.
- 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)..
- Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBF-509 | Drug | PBF-509 |
| Placebo | Drug | Placebo |
Primary outcome
Number of Adverse Events
Time frame: 5-7 days post-dose
Safety and Tolerability evaluation
1 secondary outcome
Pharmacokinetic profile analysis
Time frame: 0-24 h post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa M. Antonijoan, MD principal investigator
Centre de Investigació de Medicaments. Hospital de la Santa Creu i Sant Pau
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBF-509 in people with Parkinson Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 5-7 days post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.