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

Study Overview
=================
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'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.

Official Title
-----------------
PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTS

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Biological: PF 06687234
* Biological: [124I]IB PF 06687234


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc) Active enteric infections Other forms of colitis such as infectious colitis etc

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm - PF 06687234 and [124I]IB PF 06687234<br>PF 06687234 and [124I]IB PF 06687234 | Biological: PF 06687234<br>* Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously<br>Biological: [124I]IB PF 06687234<br>* Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma | Treatment Arm | 24 hours | 
| Standardized uptake value (SUV) in the colon (inflamed and non inflamed) | Treatment Arm | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of PF 06687234 plasma concentrations over time | Treatment Arm | 42 days | 
| AUC of plasma radioactivity concentration (% ID/kg) | Treatment Arm | 24 hours | 
| AUC in plasma, colon, liver, spleen, kidney and small intestine | Treatment Arm | 24 hours | 
| Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma | Treatment Arm | 24 hours | 
| Frequency of clinically relevant abnormalities for Safety Labs | Treatment Arm | 42 days | 
| Cmax of PF 06687234 plasma concentrations over time | Treatment Arm | 42 days | 
| Tmax of PF 06687234 plasma concentrations over time | Treatment Arm | 42 days | 
| Cmax of plasma radioactivity concentration (% ID/kg) | Treatment Arm | 24 hours | 
| Tmax of plasma radioactivity concentration (% ID/kg) | Treatment Arm | 24 hours | 
| Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine | Treatment Arm | 24 hours | 
| Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine | Treatment Arm | 24 hours | 
| Frequency of clinically relevant abnormalities for vital signs | Treatment Arm | 42 days | 
| Frequency of clinically relevant abnormalities for ECG | Treatment Arm | 42 days | 
| Frequency of clinically relevant abnormalities for Immunogenicity | Treatment Arm | 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positron Emission Tomography (PET), Inflammatory Bowel Disease, Safety, PKPlasma