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

NCT03414788 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: B7581003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

Positron Emission Tomography (PET), Inflammatory Bowel Disease, Safety, PKPlasma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• AUC of PF 06687234 plasma concentrations over time

  42 days

• AUC of plasma radioactivity concentration (% ID/kg)

  24 hours

• AUC in plasma, colon, liver, spleen, kidney and small intestine

  24 hours

• Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma

  24 hours

• Frequency of clinically relevant abnormalities for Safety Labs

  42 days

Study Arms (1)

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

EXPERIMENTAL

PF 06687234 and \[124I\]IB PF 06687234

Biological: PF 06687234; Biological: [124I]IB PF 06687234

Interventions

PF 06687234 BIOLOGICAL

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

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

[124I]IB PF 06687234 BIOLOGICAL

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 30, 2018
• Study Start: December 7, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)