NCT00480246

CompletedPhase 1

A Positron Emission Tomography (PET) Study to Assess the Deg...

BioLineRx, Ltd.Source

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Other study identifiers

Sponsor study identifier

BL- 1020.02

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

May 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

Brief 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. 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 28, 2007
Actual (reported)
First Posted
May 30, 2007
Actual (reported)

Last Updated: July 21, 2009
Status Verified: May 2007
Last Update Submitted: July 20, 2009

Conditions

Healthy

Keywords

receptor oocupancy

Interventions

BL 1020Drug

PerphenazineDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years - 35 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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).

Sponsors & Collaborators

BioLineRx, Ltd.
Industrylead

Study Sites (1)

Quintiles Phase I facility

Uppsala, Sweden

MeSH Terms

Interventions

perphenazine GABA esterPerphenazine

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Magnus Wickström
Quintiles AB, Phase I Services
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

May 28, 2007

First Posted

May 30, 2007

Study Start

May 2007

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

July 21, 2009

Record last verified: 2007-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00480246
Data provider: ClinicalTrials.gov
Source updated: 2009-07-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:17 UTC

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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.

You may not qualify if:

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).
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.
+6 more criteria

Contact the study team to confirm eligibility.

Locations

SE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

You may not qualify if:

Locations