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

Pfizer

Status and phase

Withdrawn

Phase 1

Conditions

Inflammatory Bowel Disease

Treatments

Biological: [124I]IB PF 06687234

Biological: PF 06687234

Study type

Interventional

Funder types

Industry

Identifiers

NCT03414788

B7581003

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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