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Sponsored by: |
BioLineRx, Ltd. |
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Information provided by: | BioLineRx, Ltd. |
ClinicalTrials.gov Identifier: | NCT00480246 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: BL 1020 Drug: Perphenazine |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Active Control, Parallel Assignment |
Ages Eligible for Study: | 21 Years to 35 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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.
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.
Study ID Numbers: | BL- 1020.02 |
Study First Received: | May 28, 2007 |
Last Updated: | July 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00480246 History of Changes |
Health Authority: | United States: Food and Drug Administration; Sweden: Medical Products Agency |
receptor oocupancy |
Neurotransmitter Agents Tranquilizing Agents Dopamine Perphenazine Raclopride |
Psychotropic Drugs Central Nervous System Depressants Dopamine Agents Healthy Antipsychotic Agents |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Perphenazine Therapeutic Uses Dopamine Agents Central Nervous System Agents |