A Phase 1 interventional study of PF 06687234 and [124I]IB PF 06687234 in Inflammatory Bowel Disease, sponsored by Pfizer. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Pfizer · Phase 1, Interventional, and Other
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.
Exclusion Criteria:
PF 06687234 and \[124I\]IB PF 06687234
Biological: PF 06687234 · Biological: [124I]IB PF 06687234
Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously
Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously
Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma
Treatment Arm
Time frame: 24 hours
Standardized uptake value (SUV) in the colon (inflamed and non inflamed)
Treatment Arm
Time frame: 24 hours
AUC of PF 06687234 plasma concentrations over time
Treatment Arm
Time frame: 42 days
AUC of plasma radioactivity concentration (% ID/kg)
Treatment Arm
Time frame: 24 hours
AUC in plasma, colon, liver, spleen, kidney and small intestine
Treatment Arm
Time frame: 24 hours
Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma
Treatment Arm
Time frame: 24 hours
Frequency of clinically relevant abnormalities for Safety Labs
Treatment Arm
Time frame: 42 days
Cmax of PF 06687234 plasma concentrations over time
Treatment Arm
Time frame: 42 days
Tmax of PF 06687234 plasma concentrations over time
Treatment Arm
Time frame: 42 days
Cmax of plasma radioactivity concentration (% ID/kg)
Treatment Arm
Time frame: 24 hours
Tmax of plasma radioactivity concentration (% ID/kg)
Treatment Arm
Time frame: 24 hours
Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine
Treatment Arm
Time frame: 24 hours
Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine
Treatment Arm
Time frame: 24 hours
Frequency of clinically relevant abnormalities for vital signs
Treatment Arm
Time frame: 42 days
Frequency of clinically relevant abnormalities for ECG
Treatment Arm
Time frame: 42 days
Frequency of clinically relevant abnormalities for Immunogenicity
Treatment Arm
Time frame: 42 days
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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