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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NCT03414788 — Phase 1, Withdrawn, Pfizer
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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

RegistryNCT03414788
StatusWithdrawn - The study was withdrawn due to not being able to recruit subjects.
PhasePhase 1
Study typeInterventional; na, single group, masking: none, other
SponsorPfizer (Industry)
ConditionsInflammatory Bowel Disease
InterventionsPF 06687234, [124I]IB PF 06687234 (Biological)
Datesstart 2020-12-07 (estimated), primary completion 2022-02-01 (estimated), completion 2022-02-01 (estimated), first posted 2018-01-30, last updated 2020-11-03
Locations1 site in United States

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Treatment Arm - PF 06687234 and [124I]IB PF 06687234ExperimentalBiological: PF 06687234; Biological: [124I]IB PF 06687234PF 06687234 and \[124I\]IB PF 06687234
  • PF 06687234 (Biological): Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously
  • [124I]IB PF 06687234 (Biological): Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

FacilityCityCountryStatus
New Haven Clinical Research UnitNew Haven, ConnecticutUnited States

+Investigators

  • Pfizer CT.gov Call Center, Study director, Pfizer

My Notes