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 1

Withdrawn

• Conditions: Inflammatory Bowel Disease
• Interventions: Biological: PF 06687234; Biological: [124I]IB PF 06687234

• Registration Number: NCT03414788
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-01-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-03
• Study Start: 2020-12-07
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

• Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)
• Active enteric infections
• Other forms of colitis such as infectious colitis etc

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm - PF 06687234 and [124I]IB PF 06687234	[124I]IB PF 06687234	PF 06687234 and \[124I\]IB PF 06687234
Treatment Arm - PF 06687234 and [124I]IB PF 06687234	PF 06687234	PF 06687234 and \[124I\]IB PF 06687234

Primary Outcome Measures

Name	Time	Method
Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma	24 hours	Treatment Arm
Standardized uptake value (SUV) in the colon (inflamed and non inflamed)	24 hours	Treatment Arm

Secondary Outcome Measures

Name	Time	Method
AUC of PF 06687234 plasma concentrations over time	42 days	Treatment Arm
AUC of plasma radioactivity concentration (% ID/kg)	24 hours	Treatment Arm
AUC in plasma, colon, liver, spleen, kidney and small intestine	24 hours	Treatment Arm
Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma	24 hours	Treatment Arm
Frequency of clinically relevant abnormalities for Safety Labs	42 days	Treatment Arm
Cmax of PF 06687234 plasma concentrations over time	42 days	Treatment Arm
Tmax of PF 06687234 plasma concentrations over time	42 days	Treatment Arm
Cmax of plasma radioactivity concentration (% ID/kg)	24 hours	Treatment Arm
Tmax of plasma radioactivity concentration (% ID/kg)	24 hours	Treatment Arm
Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine	24 hours	Treatment Arm
Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine	24 hours	Treatment Arm
Frequency of clinically relevant abnormalities for vital signs	42 days	Treatment Arm
Frequency of clinically relevant abnormalities for ECG	42 days	Treatment Arm
Frequency of clinically relevant abnormalities for Immunogenicity	42 days	Treatment Arm

Trial Locations

Locations (1)

New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States