Status:
WITHDRAWN
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
Lead Sponsor:
Pfizer
Conditions:
Inflammatory Bowel Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and \[124I\]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis or Crohn...
Eligibility Criteria
Inclusion
- Male and/or female subjects of non-child bearing potential, 18 years to 75 years of age inclusive at the time of informed consent
- 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
- Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)
- Active enteric infections
- Other forms of colitis such as infectious colitis etc
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03414788
Start Date
December 7 2020
End Date
February 1 2022
Last Update
November 3 2020
Active Locations (1)
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1
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511