Inflammatory Bowel Disease
Conditions
Keywords
Positron Emission Tomography (PET), Inflammatory Bowel Disease, Safety, PKPlasma
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.
Interventions
BIOLOGICALPF 06687234
Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously
BIOLOGICAL[124I]IB PF 06687234
Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| AUC of PF 06687234 plasma concentrations over time | 42 days | 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 |
| Tmax of plasma radioactivity concentration (% ID/kg) | 24 hours | Treatment Arm |
| AUC of plasma radioactivity concentration (% ID/kg) | 24 hours | Treatment Arm |
Countries
United States
Outcome results
None listed