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 Withdrawn at 1 site in United States.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
Among 15 studies in Inflammatory Bowel Diseases by Pfizer — none open to participants now, none under way, none of them phase 3. Inflammatory Bowel Diseases · Pfizer.
Among the 15 studies in Inflammatory Bowel Diseases by Pfizer, this one is the 11th largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2020, is one of 7 in phase 1, and was the 10th registered.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.
Browse Inflammatory Bowel Diseases studies →None of the 15 studies in Inflammatory Bowel Diseases by Pfizer is open now. The open studies under Inflammatory Bowel Diseases, anywhere →
Of the 277 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 117 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 3 · Phase 3 2 · Phase 4 2
First in 2002; this study’s year is marked. 2 started in 2020.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 44 across the 11 interventional studies, 1,342 across the 2 observational. Of the 14 that completed or were terminated, 9 (64%) have results posted.
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Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Inflammatory Bowel Diseases by Pfizer, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Start is estimated for Dec 2020; primary completion for Feb 2022, 13 months later.
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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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Studies of the drug tested here: PF-06687234