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A Study to Examine the Distribution of PF-06372865 in the Brain of Healthy Volunteers Using Positron Emission Tomography and a Radioactive Tracer Following Oral Administration of One Dose of PF-06372865

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ClinicalTrials.gov Identifier: NCT02138500
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study will see how PF-06372865, an experimental drug distributes in the brain after one dose of PF-06372865 is administered orally to healthy volunteer subjects. The study will also evaluate the safety and tolerability of PF-06372865in these subjects and will measure the level of PF-06372865 in the blood.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06372865 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-label Study To Evaluate Central Occupancy Of The Benzodiazepine Binding Site Of Gabaa Receptors By Positron Emission Tomography (Pet) With Ligand [11c]Flumazenil Following Single Dose Of Pf-06372865 In Healthy Subjects
Study Start Date : May 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Cohort 1: PF-06372865 10 mg Drug: PF-06372865
Single, oral dose administration of 10 mg PF-06372865 using tablet formulation.

Experimental: Cohort 2: PF-06372865 TBD dose Drug: PF-06372865
Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.

Experimental: Cohort 3: PF-06372865 TBD dose Drug: PF-06372865
Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.




Primary Outcome Measures :
  1. GABAA RO in the whole brain [ Time Frame: Change from baseline to days 1 and 2 ]
  2. Average plasma concentration of PF-06372865 in post-dose PET scans after single oral doses of PF-06372865 [ Time Frame: Change from baseline to days 1 and 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Known or suspected sensitivity to flumazenil and other benzodiazepines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138500


Locations
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United States, Connecticut
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Anlyan Center
New Haven, Connecticut, United States, 06519
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02138500     History of Changes
Other Study ID Numbers: B7431004
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Pfizer:
PF-06372865
phase 1
open-label
GABA-A receptor occupancy
positron emission tomography
healthy subjects