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

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NCT03414788

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, 06437 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 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) 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
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 Crohn's disease, infectious colitis etc

NCT03414788
Pfizer
Suspended
Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis

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Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Ulcerative Colitis
  • 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
Experimental: Treatment Arm - PF 06687234 and [124I]IB PF 06687234
PF 06687234 and [124I]IB PF 06687234
Interventions:
  • Biological: PF 06687234
  • Biological: [124I]IB PF 06687234
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
5
May 20, 2019
May 20, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03414788
B7581003
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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