HealthyPhase 1NCT00480246
A Positron Emission Tomography (PET) Study to Assess the Degree of Dopamine-2 (D2) Receptor Occupancy in the Human Brain After Single Doses of BL-1020 or Perphenazine in Healthy Male Subjects Using [11C]Raclopride as PET Tracer
A Phase 1 study testing BL 1020 and Perphenazine in people with Healthy, run by BioLineRx, Ltd. at 1 site in Sweden.
Trial summary
This is a single dose, open-label, 2-panel (Parts A and B) PET study investigating the degree of occupancy of dopamine 2 receptors (D2_RO) in the human brain after single oral doses of BL-1020 or Perphenazine (Trilafon®, hereafter called Perphenazine) in healthy male subjects. Read more about this study
- Who is it for?
- Ages 21 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BL 1020 and Perphenazine
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- May 2007to not given
- 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 21 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily signed written informed consent agreement approved by the Independent Ethics Committee (IEC) after explanation of the nature and objectives of the study and prior to any study specific procedure.
- Healthy male subjects between the age of 21 and 35 (inclusive).
- Body Mass Index (BMI) (weight [kg] / (height [m] x height [m])) ≥ 18 and < 29 kg/m2.
- Non-smokers or having refrained from smoking and other nicotine containing products for the last 1 month before dose administration.
- Good health, based upon the results of medical history, physical examination, ECG (without clinically significant abnormalities) and laboratory profile of both blood and urine, including creatinine clearance, calculated using the Cockcroft-Gault formula (upper limit for eligibility 1.5 times the upper normal limit).
- Normal blood pressure (systolic blood pressure ≥ 95 and ≤ 149 mmHg; diastolic blood pressure ≥ 55 and ≤ 89 mmHg) measured after 5 minutes rest in supine position.
- Pulse rate of ≥ 45 and ≤ 95 beats/min measured after 5 minutes rest in supine position.
- Able to communicate well with the investigator and able to comply with the requirements of the entire study.
Who cannot join
- Intake of prescribed medication or Over the Counter (OTC) medication, including herbal remedies, minerals and vitamin preparations, within 14 days prior to dosing or scheduled to receive it during the study. Paracetamol is allowed, except for within 24 hours before each PET scan.
- Demonstration of any active physical disease, acute or chronic.
- Any gastrointestinal complaints within 7 days prior to dosing day.
- Any condition which might interfere with the absorption of the investigational product, e.g. cholecystectomy (gall bladder removal, cholecystolithiasis).
- Any relevant history of chronic or recurrent metabolic (e.g., diabetes), renal, hepatic, pulmonary, gastrointestinal (e.g., gastrointestinal disease, chronic gastritis or peptic ulcers), neurological (especially history of seizures disorders), endocrinological, immunological, psychiatric or cardiovascular disease, myopathies and bleeding tendency.
- Positive test result for hepatitis B surface antigen (HBsAg), anti-Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
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- CYP2D6 genotype poor metabolizer.
- Relevant drug hypersensitivity, asthma, urticaria or other severe allergic diathesis as well as ongoing hay fever.
- Febrile or infectious illness within 7 days prior to the dosing day.
- Participation in an investigational drug study within 3 months prior to the dosing day.
- Donation of blood within 3 months prior to the dosing day.
- History of alcoholism or more than moderate alcohol consumption (> 3 units of ethanol regularly per day or > 21 units regularly per week).
- Consumption of alcohol within 48 hours prior to dose administration and/or positive alcohol breath test.
- History of drug addiction or a positive drug urine screen for amphetamine, benzodiazepine, cannabis, cocaine, methadone or opiates.
- Consumption of more than 5 cups of coffee or equivalent per day.
- Consumption of xanthine-containing food or beverages, or grapefruit juice within 48 hours prior to dose administration.
- Previous participation in a PET investigation.
- Occupational exposure to significant ionizing radiation.
- Having undergone any clinical procedure involving significant exposure to radiation (exceptions are e.g. dental X rays and common X-rays of chest or extremities), as judged by the investigator.
- Suffers from claustrophobia.
- Unsuitability for any other reason in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single dose, open-label, 2-panel (Parts A and B) PET study investigating the degree of occupancy of dopamine 2 receptors (D2_RO) in the human brain after single oral doses of BL-1020 or Perphenazine (Trilafon®, hereafter called Perphenazine) in healthy male subjects. In Part A the D2_RO is investigated for the study compound BL-1020 and in Part B the D2_RO of BL-1020 is compared to the D2_RO of Perphenazine, a reference compound.
- Conditions
- Healthy
- Being tested
- BL 1020, Perphenazine
- Keywords
- receptor oocupancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL 1020Drug
PerphenazineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- BioLineRx, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Magnus Wickström, Principal investigator, Quintiles AB, Phase I Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480246
- Sponsor's protocol ID
- BL- 1020.02
- Status last verified
- May 2007
- First submitted
- 28 May 2007
- Last updated
- 21 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Positron Emission Tomography (PET) Study to Assess the Degree of Dopamine-2 (D2) Receptor Occupancy in the Human Brain After Single Doses of BL-1020 or Perphenazine in Healthy Male Subjects Using [11C]Raclopride as PET Tracer
- ClinicalTrials.gov ID
- NCT00480246
- Acronym / sponsor ID
- BL- 1020.02
- Conditions
- Healthy
- Keywords
- receptor oocupancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- BioLineRx, Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2007
- First posted
- 30 May 2007 (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.
This is a single dose, open-label, 2-panel (Parts A and B) PET study investigating the degree of occupancy of dopamine 2 receptors (D2_RO) in the human brain after single oral doses of BL-1020 or Perphenazine (Trilafon®, hereafter called Perphenazine) in healthy male subjects. In Part A the D2_RO is investigated for the study compound BL-1020 and in Part B the D2_RO of BL-1020 is compared to the D2_RO of Perphenazine, a reference compound.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Voluntarily signed written informed consent agreement approved by the Independent Ethics Committee (IEC) after explanation of the nature and objectives of the study and prior to any study specific procedure.
- Healthy male subjects between the age of 21 and 35 (inclusive).
- Body Mass Index (BMI) (weight [kg] / (height [m] x height [m])) ≥ 18 and < 29 kg/m2.
- Non-smokers or having refrained from smoking and other nicotine containing products for the last 1 month before dose administration.
- Good health, based upon the results of medical history, physical examination, ECG (without clinically significant abnormalities) and laboratory profile of both blood and urine, including creatinine clearance, calculated using the Cockcroft-Gault formula (upper limit for eligibility 1.5 times the upper normal limit).
Key exclusion criteria (21 listed)
- Intake of prescribed medication or Over the Counter (OTC) medication, including herbal remedies, minerals and vitamin preparations, within 14 days prior to dosing or scheduled to receive it during the study. Paracetamol is allowed, except for within 24 hours before each PET scan.
- Demonstration of any active physical disease, acute or chronic.
- Any gastrointestinal complaints within 7 days prior to dosing day.
- Any condition which might interfere with the absorption of the investigational product, e.g. cholecystectomy (gall bladder removal, cholecystolithiasis).
- Any relevant history of chronic or recurrent metabolic (e.g., diabetes), renal, hepatic, pulmonary, gastrointestinal (e.g., gastrointestinal disease, chronic gastritis or peptic ulcers), neurological (especially history of seizures disorders), endocrinological, immunological, psychiatric or cardiovascular disease, myopathies and bleeding tendency.
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 |
|---|---|---|
| BL 1020 | Drug | – |
| Perphenazine | Drug | – |
Primary outcome
Not reported in the source record.
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 21 Jul 2009.
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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.
Magnus Wickström principal investigator
Quintiles AB, Phase I Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BL 1020 and Perphenazine in people with Healthy, run by BioLineRx, Ltd. at 1 site in Sweden.
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 8 inclusion and 21 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 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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. 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.
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 21 Jul 2009.