Inflammatory Bowel DiseasePhase 1NCT03414788
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
A Phase 1 study testing PF 06687234 and [124I]IB PF 06687234 in people with Inflammatory Bowel Disease, run by Pfizer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- PF 06687234 and [124I]IB PF 06687234
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2020to 1 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)
- Active enteric infections
- Other forms of colitis such as infectious colitis etc
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: 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
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
- Inflammatory Bowel Disease
- Being tested
- PF 06687234, [124I]IB PF 06687234
- Keywords
- Positron Emission Tomography (PET), Inflammatory Bowel Disease, Safety, PKPlasma
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF 06687234Biological
Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously
[124I]IB PF 06687234Biological
Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm - PF 06687234 and [124I]IB PF 06687234 | Experimental | PF 06687234 and [124I]IB PF 06687234 Receives: Biological: PF 06687234; Biological: [124I]IB PF 06687234 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma
Treatment Arm
Measured: 24 hours
Standardized uptake value (SUV) in the colon (inflamed and non inflamed)
Treatment Arm
Measured: 24 hours
Secondary outcomes (14)
AUC of PF 06687234 plasma concentrations over time
Treatment Arm
Measured: 42 days
AUC of plasma radioactivity concentration (% ID/kg)
Treatment Arm
Measured: 24 hours
AUC in plasma, colon, liver, spleen, kidney and small intestine
Treatment Arm
Measured: 24 hours
Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma
Treatment Arm
Measured: 24 hours
Frequency of clinically relevant abnormalities for Safety Labs
Treatment Arm
Measured: 42 days
Cmax of PF 06687234 plasma concentrations over time
Treatment Arm
Measured: 42 days
Tmax of PF 06687234 plasma concentrations over time
Treatment Arm
Measured: 42 days
Cmax of plasma radioactivity concentration (% ID/kg)
Treatment Arm
Measured: 24 hours
Tmax of plasma radioactivity concentration (% ID/kg)
Treatment Arm
Measured: 24 hours
Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine
Treatment Arm
Measured: 24 hours
Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine
Treatment Arm
Measured: 24 hours
Frequency of clinically relevant abnormalities for vital signs
Treatment Arm
Measured: 42 days
Frequency of clinically relevant abnormalities for ECG
Treatment Arm
Measured: 42 days
Frequency of clinically relevant abnormalities for Immunogenicity
Treatment Arm
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start7 Dec 2020 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Why it stopped: The study was withdrawn due to not being able to recruit subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414788
- Sponsor's protocol ID
- B7581003
- Status last verified
- Oct 2020
- First submitted
- 8 Jan 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03414788
- Acronym / sponsor ID
- B7581003
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Positron Emission Tomography (PET), Inflammatory Bowel Disease, Safety, PKPlasma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to not being able to recruit subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2020 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm - PF 06687234 and [124I]IB PF 06687234 | Experimental | Biological: PF 06687234, Biological: [124I]IB PF 06687234PF 06687234 and [124I]IB PF 06687234 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)
- Active enteric infections
- Other forms of colitis such as infectious colitis etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF 06687234Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously | Biological | Treatment Arm - PF 06687234 and [124I]IB PF 06687234 |
| [124I]IB PF 06687234Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously | Biological | Treatment Arm - PF 06687234 and [124I]IB PF 06687234 |
Primary outcome
Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma
Time frame: 24 hours
Treatment Arm
Standardized uptake value (SUV) in the colon (inflamed and non inflamed)
Time frame: 24 hours
Treatment Arm
14 secondary outcomes
AUC of PF 06687234 plasma concentrations over time
Time frame: 42 days
AUC of plasma radioactivity concentration (% ID/kg)
Time frame: 24 hours
AUC in plasma, colon, liver, spleen, kidney and small intestine
Time frame: 24 hours
Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma
Time frame: 24 hours
Frequency of clinically relevant abnormalities for Safety Labs
Time frame: 42 days
Cmax of PF 06687234 plasma concentrations over time
Time frame: 42 days
Tmax of PF 06687234 plasma concentrations over time
Time frame: 42 days
Cmax of plasma radioactivity concentration (% ID/kg)
Time frame: 24 hours
Tmax of plasma radioactivity concentration (% ID/kg)
Time frame: 24 hours
Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine
Time frame: 24 hours
Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine
Time frame: 24 hours
Frequency of clinically relevant abnormalities for vital signs
Time frame: 42 days
Frequency of clinically relevant abnormalities for ECG
Time frame: 42 days
Frequency of clinically relevant abnormalities for Immunogenicity
Time frame: 42 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF 06687234 and [124I]IB PF 06687234 in people with Inflammatory Bowel Disease, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.