drugset / Trial / NCT03414788
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
NaSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2020-12-07
- Primary completion
- 2022-02-01
- Completion
- 2022-02-01
Outcome
Outcome not reported
Stopped (Enrollment): “The study was withdrawn due to not being able to recruit subjects.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PF-06687234 | Protein / enzyme biologic | — | Intravenous |
| Subject | [124I]IB PF 06687234 | Unknown | — | Intravenous |