Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414788
Recruitment Status : Withdrawn (The study was withdrawn due to not being able to recruit subjects.)
First Posted : January 30, 2018
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Biological: PF 06687234 Biological: [124I]IB PF 06687234 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : December 7, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma [ Time Frame: 24 hours ]
    Treatment Arm

  2. Standardized uptake value (SUV) in the colon (inflamed and non inflamed) [ Time Frame: 24 hours ]
    Treatment Arm


Secondary Outcome Measures :
  1. AUC of PF 06687234 plasma concentrations over time [ Time Frame: 42 days ]
    Treatment Arm

  2. AUC of plasma radioactivity concentration (% ID/kg) [ Time Frame: 24 hours ]
    Treatment Arm

  3. AUC in plasma, colon, liver, spleen, kidney and small intestine [ Time Frame: 24 hours ]
    Treatment Arm

  4. Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma [ Time Frame: 24 hours ]
    Treatment Arm

  5. Frequency of clinically relevant abnormalities for Safety Labs [ Time Frame: 42 days ]
    Treatment Arm

  6. Cmax of PF 06687234 plasma concentrations over time [ Time Frame: 42 days ]
    Treatment Arm

  7. Tmax of PF 06687234 plasma concentrations over time [ Time Frame: 42 days ]
    Treatment Arm

  8. Cmax of plasma radioactivity concentration (% ID/kg) [ Time Frame: 24 hours ]
    Treatment Arm

  9. Tmax of plasma radioactivity concentration (% ID/kg) [ Time Frame: 24 hours ]
    Treatment Arm

  10. Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine [ Time Frame: 24 hours ]
    Treatment Arm

  11. Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine [ Time Frame: 24 hours ]
    Treatment Arm

  12. Frequency of clinically relevant abnormalities for vital signs [ Time Frame: 42 days ]
    Treatment Arm

  13. Frequency of clinically relevant abnormalities for ECG [ Time Frame: 42 days ]
    Treatment Arm

  14. Frequency of clinically relevant abnormalities for Immunogenicity [ Time Frame: 42 days ]
    Treatment Arm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414788


Locations
Layout table for location information
United States, Connecticut
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03414788    
Other Study ID Numbers: B7581003
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Positron Emission Tomography (PET), Inflammatory Bowel Disease, Safety, PKPlasma
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases