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
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inflammatory Bowel Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Clinically significant/unstable clinical conditions (eg. cancer hematological,
endocrine etc)
- Active enteric infections
- Other forms of colitis such as infectious colitis etc
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Inflammatory Bowel DiseaseDistribution 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
- New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | 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 | ||||
| Official Title ICMJE | 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 | ||||
| Brief 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other | ||||
| Condition ICMJE | Inflammatory Bowel Disease | ||||
| Intervention ICMJE |
| ||||
| Study Arms ICMJE | Experimental: Treatment Arm - PF 06687234 and [124I]IB PF 06687234
PF 06687234 and [124I]IB PF 06687234 Interventions:
| ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Actual Enrollment ICMJE | 0 | ||||
| Original Estimated Enrollment ICMJE | 5 | ||||
| Estimated Study Completion Date ICMJE | February 1, 2022 | ||||
| Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03414788 | ||||
| Other Study ID Numbers ICMJE | B7581003 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||