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The study was withdrawn due to not being able to recruit subjects.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm - PF 06687234 and [124I]IB PF 06687234 | Experimental | PF 06687234 and [124I]IB PF 06687234 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF 06687234 | Biological | Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of PF 06687234 plasma concentrations over time | Treatment Arm | 42 days |
| AUC of plasma radioactivity concentration (% ID/kg) | Treatment Arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| [124I]IB PF 06687234 | Biological | Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously |
|
| 24 hours |
| AUC in plasma, colon, liver, spleen, kidney and small intestine | Treatment Arm | 24 hours |
| Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma | Treatment Arm | 24 hours |
| Frequency of clinically relevant abnormalities for Safety Labs | Treatment Arm | 42 days |
| Cmax of PF 06687234 plasma concentrations over time | Treatment Arm | 42 days |
| Tmax of PF 06687234 plasma concentrations over time | Treatment Arm | 42 days |
| Cmax of plasma radioactivity concentration (% ID/kg) | Treatment Arm | 24 hours |
| Tmax of plasma radioactivity concentration (% ID/kg) | Treatment Arm | 24 hours |
| Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine | Treatment Arm | 24 hours |
| Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine | Treatment Arm | 24 hours |
| Frequency of clinically relevant abnormalities for vital signs | Treatment Arm | 42 days |
| Frequency of clinically relevant abnormalities for ECG | Treatment Arm | 42 days |
| Frequency of clinically relevant abnormalities for Immunogenicity | Treatment Arm | 42 days |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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