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

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03414788
• Other study ID #: B7581003
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 7, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: October 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma	Treatment Arm	24 hours
Primary	Standardized uptake value (SUV) in the colon (inflamed and non inflamed)	Treatment Arm	24 hours
Secondary	AUC of PF 06687234 plasma concentrations over time	Treatment Arm	42 days
Secondary	AUC of plasma radioactivity concentration (% ID/kg)	Treatment Arm	24 hours
Secondary	AUC in plasma, colon, liver, spleen, kidney and small intestine	Treatment Arm	24 hours
Secondary	Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma	Treatment Arm	24 hours
Secondary	Frequency of clinically relevant abnormalities for Safety Labs	Treatment Arm	42 days
Secondary	Cmax of PF 06687234 plasma concentrations over time	Treatment Arm	42 days
Secondary	Tmax of PF 06687234 plasma concentrations over time	Treatment Arm	42 days
Secondary	Cmax of plasma radioactivity concentration (% ID/kg)	Treatment Arm	24 hours
Secondary	Tmax of plasma radioactivity concentration (% ID/kg)	Treatment Arm	24 hours
Secondary	Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine	Treatment Arm	24 hours
Secondary	Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine	Treatment Arm	24 hours
Secondary	Frequency of clinically relevant abnormalities for vital signs	Treatment Arm	42 days
Secondary	Frequency of clinically relevant abnormalities for ECG	Treatment Arm	42 days
Secondary	Frequency of clinically relevant abnormalities for Immunogenicity	Treatment Arm	42 days

External Links

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