Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease
NCT ID: NCT03414788
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2020-12-07
2022-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Treatment Arm - PF 06687234 and [124I]IB PF 06687234
PF 06687234 and \[124I\]IB PF 06687234
PF 06687234
Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously
[124I]IB PF 06687234
Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously
Interventions
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PF 06687234
Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously
[124I]IB PF 06687234
Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously
Eligibility Criteria
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Inclusion Criteria
* Only women of non-child bearing potential
* Diagnosis of active UC (histologic) or CD prior to study entry for a minimum of 4 months
* Subjects with moderate to severe, active UC as defined by Mayo endoscopic index of at least 2; or subjects with moderate to severe, active CD as defined by SES-CD score of at least 7.
Exclusion Criteria
* Active enteric infections
* Other forms of colitis such as infectious colitis etc
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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New Haven Clinical Research Unit
New Haven, Connecticut, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B7581003
Identifier Type: -
Identifier Source: org_study_id