HealthyPhase 1NCT02410525
A Study Testing A Radioactive Compound Given Through A Vein With And Without The Non-Radioactive Compound, Given By Mouth, To Characterize Tissue Distribution Using Positron Emission Tomography Scanning
A Phase 1 study testing [11C]PF-06427878, PF-06427878 10 mg and PF-06427878 600 mg in people with Healthy, run by Pfizer at 3 sites in United States.
Trial summary
In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2 different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects. Positron emission tomography will be used to characterize tissue distribution. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [11C]PF-06427878, PF-06427878 10 mg and PF-06427878 600 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2015to Sep 2015
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males
- body mass index 17.5-30.5 kg/m2 ; body weight >50 kg
- signed and dated informed consent document
- willing and able to comply with study requirements
Who cannot join
- tobacco/nicotine containing products > equivalent of 5 cigarettes per day
- history of cumulative ionizing radiation exposure in the past year, including anticipated exposure in this study, and subjects with current, past or anticipated exposure to radiation in the workplace
- severe claustrophobia
- unable to lie still for the required period to acquire images
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
Anylan Center
New Haven, Connecticut, 06519
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: A Phase 1, Open-label, 3-period, Randomized, Partially Fixed Sequence, 2-way Crossover Study With A Microdose Of [11c]Pf-06427878 Administered With And Without Two Non-radioactive Doses Of Pf-06427878 To Characterize Tissue Distribution Using Positron Emission Tomography In Healthy Adult Male Subjects
In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2 different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects. Positron emission tomography will be used to characterize tissue distribution. The study will also characterize how the study drug behaves in the body, its safety, and how the body tolerates it.
- Conditions
- Healthy
- Being tested
- [11C]PF-06427878, PF-06427878 10 mg, PF-06427878 600 mg
- Keywords
- hyperlipidemia, positron emission tomography
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]PF-06427878Drug
Single administration via intravenous infusion of 20 ug [11C]PF-06427878 on Day 1 of all 3 Periods
PF-06427878 10 mgDrug
Single oral administration of 10 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration
PF-06427878 600 mgDrug
Single oral administration of 600 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration
| Study group | Role | What they receive |
|---|---|---|
| [11C]PF-06427878 | Experimental | Single intravenous infusion of [11C]PF-06427878 in Periods 1, 2 and 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability Receives: Drug: [11C]PF-06427878 |
| PF-06427878 10 mg | Experimental | Single oral dose of 10 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability Receives: Drug: PF-06427878 10 mg |
| PF-06427878 600 mg | Experimental | Single oral dose of 600 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability Receives: Drug: PF-06427878 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent injected radioactivity (per gram) over time in the liver
Measured: All Periods;Day 1;0-120min
Percent injected radioactivity (per gram) over time in the plasma
Measured: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Secondary outcomes (22)
Relative radioactivity in liver versus plasma
Ratio of AUC of percent injected radioactivity (per gram) over time in liver to AUC of percent injected radioactivity (per gram) over time in plasma
Measured: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the gall bladder, if this region is identifiable
Measured: All Periods;Day 1;0-2hr
% of parent in plasma over time
Parent is study drug PF-06427878
Measured: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Plasma PK of PF-06427878: AUClast, as data permit
Measured: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: AUClast, as data permit.
Measured: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the biliary tree, if this region is identifiable
Measured: All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the abdominal fat, if this region is identifiable
Measured: All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the kidney, if this region is identifiable
Measured: All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the urinary bladder, if this region is identifiable
Measured: All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the thigh muscle, if this region is identifiable
Measured: All Periods;Day 1;0-2hr
Plasma PK of PF-06427878: AUCinf, as data permit
Measured: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Cmax, as data permit
Measured: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Tmax, as data permit
Measured: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: t½, as data permit
Measured: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: CL, as data permit
Measured: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Vss, as data permit
Measured: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Vss, as data permit.
Measured: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: AUCinf, as data permit.
Measured: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: Cmax, as data permit.
Measured: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: Tmax, as data permit.
Measured: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: t½, as data permit.
Measured: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: CL/F, as data permit.
Measured: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT02410525
- Sponsor's protocol ID
- B7871003
- Status last verified
- Oct 2015
- First submitted
- 2 Apr 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 3-period, Randomized, Partially Fixed Sequence, 2-way Crossover Study With A Microdose Of [11c]Pf-06427878 Administered With And Without Two Non-radioactive Doses Of Pf-06427878 To Characterize Tissue Distribution Using Positron Emission Tomography In Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT02410525
- Acronym / sponsor ID
- B7871003
- Conditions
- Healthy
- Keywords
- hyperlipidemia, positron emission tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Apr 2015 (estimated)
- 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.
In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2 different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects. Positron emission tomography will be used to characterize tissue distribution. The study will also characterize how the study drug behaves in the body, its safety, and how the body tolerates it.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| [11C]PF-06427878 | Experimental | Drug: [11C]PF-06427878Single intravenous infusion of [11C]PF-06427878 in Periods 1, 2 and 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability |
| PF-06427878 10 mg | Experimental | Drug: PF-06427878 10 mgSingle oral dose of 10 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability |
| PF-06427878 600 mg | Experimental | Drug: PF-06427878 600 mgSingle oral dose of 600 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy males
- body mass index 17.5-30.5 kg/m2 ; body weight >50 kg
- signed and dated informed consent document
- willing and able to comply with study requirements
Key exclusion criteria (4 listed)
- tobacco/nicotine containing products > equivalent of 5 cigarettes per day
- history of cumulative ionizing radiation exposure in the past year, including anticipated exposure in this study, and subjects with current, past or anticipated exposure to radiation in the workplace
- severe claustrophobia
- unable to lie still for the required period to acquire images
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 |
|---|---|---|
| [11C]PF-06427878Single administration via intravenous infusion of 20 ug [11C]PF-06427878 on Day 1 of all 3 Periods | Drug | [11C]PF-06427878 |
| PF-06427878 10 mgSingle oral administration of 10 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration | Drug | PF-06427878 10 mg |
| PF-06427878 600 mgSingle oral administration of 600 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration | Drug | PF-06427878 600 mg |
Primary outcome
Percent injected radioactivity (per gram) over time in the liver
Time frame: All Periods;Day 1;0-120min
Percent injected radioactivity (per gram) over time in the plasma
Time frame: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
22 secondary outcomes
Relative radioactivity in liver versus plasma
Time frame: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the gall bladder, if this region is identifiable
Time frame: All Periods;Day 1;0-2hr
% of parent in plasma over time
Time frame: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Plasma PK of PF-06427878: AUClast, as data permit
Time frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: AUClast, as data permit.
Time frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the biliary tree, if this region is identifiable
Time frame: All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the abdominal fat, if this region is identifiable
Time frame: All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the kidney, if this region is identifiable
Time frame: All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the urinary bladder, if this region is identifiable
Time frame: All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the thigh muscle, if this region is identifiable
Time frame: All Periods;Day 1;0-2hr
Plasma PK of PF-06427878: AUCinf, as data permit
Time frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Cmax, as data permit
Time frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Tmax, as data permit
Time frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: t½, as data permit
Time frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: CL, as data permit
Time frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Vss, as data permit
Time frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Vss, as data permit.
Time frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: AUCinf, as data permit.
Time frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: Cmax, as data permit.
Time frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: Tmax, as data permit.
Time frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: t½, as data permit.
Time frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: CL/F, as data permit.
Time frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [11C]PF-06427878, PF-06427878 10 mg and PF-06427878 600 mg in people with Healthy, run by Pfizer at 3 sites 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 4 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: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (per gram) over time in the liver (time frame: All Periods;Day 1;0-120min). 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 29 Oct 2015.