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

Pfizer

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Inflammatory Bowel Disease

Interventions

PF 06687234BIOLOGICAL

Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously

[124I]IB PF 06687234BIOLOGICAL

Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

New Haven Clinical Research Unit

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma

Treatment Arm

Time frame: 24 hours

Standardized uptake value (SUV) in the colon (inflamed and non inflamed)

Treatment Arm

Time frame: 24 hours

Secondary Outcomes

AUC of PF 06687234 plasma concentrations over time

Treatment Arm

Time frame: 42 days

AUC of plasma radioactivity concentration (% ID/kg)

Treatment Arm

Time frame: 24 hours

AUC in plasma, colon, liver, spleen, kidney and small intestine

Treatment Arm

Time frame: 24 hours

Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma

Treatment Arm

Time frame: 24 hours

Frequency of clinically relevant abnormalities for Safety Labs

Treatment Arm

Time frame: 42 days

Cmax of PF 06687234 plasma concentrations over time

Treatment Arm

Time frame: 42 days

Tmax of PF 06687234 plasma concentrations over time

Treatment Arm

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.