Trials / Withdrawn
WithdrawnNCT03414788
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
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 AND CROHN'S COLITIS SUBJECTS
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PF 06687234 | Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously |
| BIOLOGICAL | [124I]IB PF 06687234 | Subjects will be given single, intravenous dose of PF 06687234 and \[124I\]IB PF 06687234 simultaneously |
Timeline
- Start date
- 2020-12-07
- Primary completion
- 2022-02-01
- Completion
- 2022-02-01
- First posted
- 2018-01-30
- Last updated
- 2020-11-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03414788. Inclusion in this directory is not an endorsement.