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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

Primary Purpose

Inflammatory Bowel Disease

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF 06687234
[124I]IB PF 06687234
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammatory Bowel Disease focused on measuring Positron Emission Tomography (PET), Inflammatory Bowel Disease, Safety, PKPlasma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New Haven Clinical Research Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm - PF 06687234 and [124I]IB PF 06687234

Arm Description

PF 06687234 and [124I]IB PF 06687234

Outcomes

Primary Outcome Measures

Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma
Treatment Arm
Standardized uptake value (SUV) in the colon (inflamed and non inflamed)
Treatment Arm

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2018
Last Updated
October 30, 2020
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03414788
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The study was withdrawn due to not being able to recruit subjects.
Study Start Date
December 7, 2020 (Anticipated)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Positron Emission Tomography (PET), Inflammatory Bowel Disease, Safety, PKPlasma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm - PF 06687234 and [124I]IB PF 06687234
Arm Type
Experimental
Arm Description
PF 06687234 and [124I]IB PF 06687234
Intervention Type
Biological
Intervention Name(s)
PF 06687234
Intervention Description
Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously
Intervention Type
Biological
Intervention Name(s)
[124I]IB PF 06687234
Intervention Description
Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously
Primary Outcome Measure Information:
Title
Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma
Description
Treatment Arm
Time Frame
24 hours
Title
Standardized uptake value (SUV) in the colon (inflamed and non inflamed)
Description
Treatment Arm
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
AUC of PF 06687234 plasma concentrations over time
Description
Treatment Arm
Time Frame
42 days
Title
AUC of plasma radioactivity concentration (% ID/kg)
Description
Treatment Arm
Time Frame
24 hours
Title
AUC in plasma, colon, liver, spleen, kidney and small intestine
Description
Treatment Arm
Time Frame
24 hours
Title
Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma
Description
Treatment Arm
Time Frame
24 hours
Title
Frequency of clinically relevant abnormalities for Safety Labs
Description
Treatment Arm
Time Frame
42 days
Title
Cmax of PF 06687234 plasma concentrations over time
Description
Treatment Arm
Time Frame
42 days
Title
Tmax of PF 06687234 plasma concentrations over time
Description
Treatment Arm
Time Frame
42 days
Title
Cmax of plasma radioactivity concentration (% ID/kg)
Description
Treatment Arm
Time Frame
24 hours
Title
Tmax of plasma radioactivity concentration (% ID/kg)
Description
Treatment Arm
Time Frame
24 hours
Title
Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine
Description
Treatment Arm
Time Frame
24 hours
Title
Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine
Description
Treatment Arm
Time Frame
24 hours
Title
Frequency of clinically relevant abnormalities for vital signs
Description
Treatment Arm
Time Frame
42 days
Title
Frequency of clinically relevant abnormalities for ECG
Description
Treatment Arm
Time Frame
42 days
Title
Frequency of clinically relevant abnormalities for Immunogenicity
Description
Treatment Arm
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
New Haven Clinical Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7581003
Description
To obtain contact information for a study center near you, click here.

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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

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