Clinical trial NCT03414788: 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
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Inflammatory Bowel Disease
Keywords: Positron Emission Tomography (PET), Inflammatory Bowel Disease, Safety, PKPlasma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma
timeFrame: 24 hours
measure: Standardized uptake value (SUV) in the colon (inflamed and non inflamed)
timeFrame: 24 hours
Secondary outcomes:
measure: AUC of PF 06687234 plasma concentrations over time
timeFrame: 42 days
measure: AUC of plasma radioactivity concentration (% ID/kg)
timeFrame: 24 hours
measure: AUC in plasma, colon, liver, spleen, kidney and small intestine
timeFrame: 24 hours
measure: Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma
timeFrame: 24 hours
measure: Frequency of clinically relevant abnormalities for Safety Labs
timeFrame: 42 days
measure: Cmax of PF 06687234 plasma concentrations over time
timeFrame: 42 days
measure: Tmax of PF 06687234 plasma concentrations over time
timeFrame: 42 days
measure: Cmax of plasma radioactivity concentration (% ID/kg)
timeFrame: 24 hours
measure: Tmax of plasma radioactivity concentration (% ID/kg)
timeFrame: 24 hours
measure: Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine
timeFrame: 24 hours
measure: Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine
timeFrame: 24 hours
measure: Frequency of clinically relevant abnormalities for vital signs
timeFrame: 42 days
measure: Frequency of clinically relevant abnormalities for ECG
timeFrame: 42 days
measure: Frequency of clinically relevant abnormalities for Immunogenicity
timeFrame: 42 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: