AsthmaPhase 1NCT02208973
Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-680 After Multiple Oral Doses"
A Phase 1 study testing PBF-680 in people with Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- PBF-680
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- May 2014to Dec 2014
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects meeting all the following inclusion criteria at screening visit:
- 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).
Who cannot join
- 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.
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- 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.
- Having donated blood during 4 weeks period before inclusion in the study.
- 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.
- 12 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).
- Positive results from the HIV serology.
- Females with positive results from the pregnancy test or breast-feeding.
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
CIM-Sant Pau - IIB Sant Pau, HSCSP
Barcelona, Barcelona, 08025
Palobiofarma S.L. (molecule owner)
Mataró, Barcelona, 08302
About this study
Official title: Randomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-680 "After Multiple Oral Doses" in Healthy Volunteers.
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
- Being tested
- PBF-680, Placebo
- Keywords
- Adenosine A1 receptor antagonist, adenosine receptor modulator, Asthma, COPD
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBF-680Drug
5, 10, 20, 40 and 60 mg of PBF-680
PlaceboDrug
placebo for the dose of 5, 10, 20 and 40 mg of PBF-680
| Study group | Role | What they receive |
|---|---|---|
| PBF-680 (5 mg) | Experimental | 5 mg of PBF-680 Receives: Drug: PBF-680 |
| PBF-680 (10 mg) | Experimental | 10 mg of PBF-680 Receives: Drug: PBF-680 |
| PBF-680 (20 mg) | Experimental | 20 mg of PBF-680 Receives: Drug: PBF-680 |
| PBF-680 (40 mg) | Experimental | 40 mg of PBF-680 Receives: Drug: PBF-680 |
| PBF-680 (60 mg) | Experimental | 60 mg of PBF-680 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious and Non-Serious Adverse Events
Vital Signs, ECG recordings, laboratory safety test and phisical examination will be performed
Measured: from day 0 to day 15
Secondary outcomes (1)
Pharmacokinetic Profile Analysis (Plasma concentrations)
- Day 1: baseline [pre-dose], [+10 min], [+20 min], [+40min], [+60min], [+ 1.5h], [+2 h], [+ 2.5 h], [+ 3 h], [+ 4h], [+8h], [+ 12h] and [+16h] post-medication;
- Days 2 to 7: baseline [daily pre-dose] which corresponds at +24h of previous dose;
- Day 8: baseline [daily pre-dose], [+10 min], [+20 min], [+40min], [+60min], [+1.5h], [+2 h], [+ 2.5 h], [+ 3 h], [+ 4h], [+8h], [+ 12h] and [+16h] and [+ 24h] post-daily medication (D9).
Measured: from day 1 to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Palo Biofarma, S.L
- Responsible party
- Sponsor
- Investigators
- Joan Martínez Colomer, MD, Principal investigator, CIM Sant Pau - IIB Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208973
- Sponsor's protocol ID
- IIBSP-PBF-2014-04
- Other IDs
- 2014-000425-20, 2014
- Status last verified
- Mar 2016
- First submitted
- 4 Aug 2014
- 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, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-680 "After Multiple Oral Doses" in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02208973
- Acronym / sponsor ID
- IIBSP-PBF-2014-04
- Conditions
- Asthma
- Keywords
- Adenosine A1 receptor antagonist, adenosine receptor modulator, Asthma, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 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
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Aug 2014 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PBF-680 (5 mg) | Experimental | Drug: PBF-6805 mg of PBF-680 |
| PBF-680 (10 mg) | Experimental | Drug: PBF-68010 mg of PBF-680 |
| PBF-680 (20 mg) | Experimental | Drug: PBF-68020 mg of PBF-680 |
| PBF-680 (40 mg) | Experimental | Drug: PBF-68040 mg of PBF-680 |
| PBF-680 (60 mg) | Experimental | Drug: PBF-68060 mg of PBF-680 |
| Placebo | Placebo comparator | Drug: PlaceboComparator 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects meeting all the following inclusion criteria at screening visit:
Key exclusion criteria (22 listed)
- Subjects meeting any of the following criteria at screening visit will be excluded from entry into the study:
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-6805, 10, 20, 40 and 60 mg of PBF-680 | Drug | PBF-680 (10 mg), PBF-680 (20 mg), PBF-680 (40 mg), PBF-680 (5 mg), PBF-680 (60 mg) |
| Placeboplacebo for the dose of 5, 10, 20 and 40 mg of PBF-680 | Drug | Placebo |
Primary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: from day 0 to day 15
Vital Signs, ECG recordings, laboratory safety test and phisical examination will be performed
1 secondary outcome
Pharmacokinetic Profile Analysis (Plasma concentrations)
Time frame: from day 1 to day 8
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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Joan Martínez Colomer, MD principal investigator
CIM Sant Pau - IIB 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-680 in people with Asthma, 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 22 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 Participants with Serious and Non-Serious Adverse Events (time frame: from day 0 to day 15). 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.