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

NCT03414788 ↗

Phase 1 Withdrawn Pfizer
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Stopped (Enrollment): “The study was withdrawn due to not being able to recruit subjects.”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

EvaluationDrugModalityDoseRoute
Subject PF-06687234 Protein / enzyme biologic — Intravenous
Subject [124I]IB PF 06687234 Unknown — Intravenous