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

Withdrawn before enrolling · Phase 1

Conditions studied: Inflammatory Bowel Disease

In brief

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's Disease. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and \[124I\]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.

Key facts

Study ID

NCT03414788

Run by

Pfizer

People needed

0

Starts

2020-12-07

Expected to finish

2022-02-01

Last updated by the study team

2020-11-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)
• Active enteric infections
• Other forms of colitis such as infectious colitis etc

Where it is running

• New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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