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

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

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 Overview

• Status: Withdrawn
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Biological: PF 06687234; Biological: [124I]IB PF 06687234

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 7, 2020
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Positron Emission Tomography (PET), Inflammatory Bowel Disease, Safety, PKPlasma
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Colitis
• Other Study ID Numbers: B7581003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No