Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis

Status:	Suspended
Conditions:	Colitis, Colitis, Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 75
Updated:	3/27/2019
Start Date:	September 4, 2019
End Date:	October 29, 2020

PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB) PF 06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF 06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE COLITIS SUBJECTS

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. 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.

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) prior to study entry for a minimum of 4 months

- Subjects with moderate to severe, active UC as defined by Mayo stool frequency
subscore of > 1, and/or rectal bleeding subscore of > 1

- Mayo Endoscopic subscore of at least 2 for a portion of inflamed segment

Exclusion Criteria:

- Clinically significant/unstable clinical conditions (eg. cancer hematological,
endocrine etc)

- Active enteric infections

- Other forms of colitis such as Crohn's disease, infectious colitis etc

We found this trial at

sites

New Haven Clinical Research Unit

New Haven, Connecticut 06511

from

New Haven, CT