Healthy VolunteersPhase 1B7981011NCT03929510

Study to Characterize Absorption, Distribution, Metabolism and Excretion of 14C PF-06651600 and to Evaluate the Absolute Oral Bioavailability and Fraction Absorbed of PF-06651600.

A Phase 1 study testing 14C-PF-06651600, 14C-PF-06651600 IV and PF-06651600 in people with Healthy Volunteers, run by Pfizer at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will investigate the absorption, distribution, metabolism and excretion (ADME) of 14C PF-06651600 and characterize plasma, fecal and urinary radioactivity and identify any metabolites, if possible, of 14C PF-06651600 in humans. 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 Volunteers
What is being tested?: 14C-PF-06651600, 14C-PF-06651600 IV and PF-06651600
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 2 sitesNetherlands
Study dates: 23 Apr 2019to 5 Jul 2019
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

Male participants who are healthy as determined by medical evaluation including a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12 lead ECG, and clinical laboratory tests.
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Who cannot join

Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
Infection with hepatitis B or hepatitis C viruses.
Participants with selected acute or chronic infections or infection history.
Participants have a known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
Use of tobacco/nicotine containing products within 3 months prior to dosing or positive urine cotinine test.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

PRA Health Sciences
Groningen, 9728 NZ
PRA Health Sciences Utrecht
Utrecht, 3584 BL

Other trials in Netherlands

About this study

Official title: A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-PF-06651600 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06651600 IN HEALTHY MALE PARTICIPANTS USING A 14C-MICROTRACER APPROACH

Conditions: Healthy Volunteers
Being tested: 14C-PF-06651600, 14C-PF-06651600 IV, PF-06651600
Keywords: Phase 1, Male, healthy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

14C-PF-06651600Drug
Oral solution of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi radioactivity
14C-PF-06651600 IVDrug
IV solution 60 micrograms of 14C labeled PF-06651600 containing approximately 300 nCi radioactivity
PF-06651600Drug
Oral solution 200mg

Study groups in NCT03929510
Study group	Role	What they receive
Period A	Experimental	Single oral dose of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF 06651600). Receives: Drug: 14C-PF-06651600
Period B	Experimental	Single oral dose of 200 milligrams (mg) unlabeled PF-06651600 followed at time of peak plasma concentration (Tmax) by an Intravenous (IV) dose of 60 micrograms.14C -PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF-06651600). Receives: Drug: 14C-PF-06651600 IV; Drug: PF-06651600

What is being measured

The primary outcome is the main question the study is designed to answer.

Mass Balance: Cumulative recovery (%) of radioactivity in urine
Cumulative recovery (%) of radioactivity in urine.
Measured: from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24
Mass Balance: Cumulative recovery (%) of radioactivity in feces
Cumulative recovery (%) of radioactivity in feces
Measured: from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24

Secondary outcomes (18)

Amount (% of the administered dose) of major metabolites of PF-06651600 in plasma
Measured: Hour 0 up to 312 hours post-dose.
Amount (% of the administered dose) of major metabolites of PF-06651600 in urine
Measured: Hour 0 up to 312 hours post-dose.
Amount (% of the administered dose) of major metabolites of PF-06651600 in feces
Measured: Hour 0 up to 312 hours post-dose.
Cmax
Maximum plasma concentration
Measured: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
AUClast
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)
Measured: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
AUCinf
Area under the plasma concentration time profile from time 0 to infinity
Measured: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
Tmax
Time for Cmax
Measured: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
t1/2
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
CL (IV)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
Measured: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
CL/F (oral)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
Measured: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
Vss
Steady state volume of distribution following IV infusion
Measured: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
Vz/F
Apparent volume of distribution following oral administration
Measured: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
Total 14C_Urine_PO
Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following oral administration of 14C PF 06651600 microtracer dose
Measured: Pre-dose, Day1, day 2, day 3, day 4, day 5, day 6 and day 7 post-dose
Total 14C_Urine_IV
Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following IV administration of 14C PF 06651600 microtracer dose
Measured: Pre-dose, Day1, day 2, day 3, day 4, day 5, day 6 and day 7 post-dose
AE
Number of subjects and number of AEs which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug.
Measured: Baseline (Day 0) up to 90 days after last dose of study medication
Number of participants with clinically significant changes to the physical examination
clinically significant changes to the physical examination
Measured: Baseline (Day 0) up to Day 24
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) obtained from each participant. Clinical significance of vital signs was determined at the investigator's discretion.
Measured: Baseline (Day 0) up to Day 24
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Laboratory parameters include: hematological and chemical parameters
Measured: Baseline (Day 0) up to Day 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 20195 Jul 2019

First posted29 Apr 2019
Study start23 Apr 2019
Primary completion5 Jul 2019
Study completion5 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03929510
Sponsor's protocol ID: B7981011
Other IDs: 2018-003551-38, 2018
Acronym: B7981011
Status last verified: Jul 2019
First submitted: 17 Apr 2019
Last updated: 24 Jul 2019
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-PF-06651600 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06651600 IN HEALTHY MALE PARTICIPANTS USING A 14C-MICROTRACER APPROACH
ClinicalTrials.gov ID: NCT03929510
Acronym / sponsor ID: B7981011 / B7981011
Conditions: Healthy Volunteers
Keywords: Phase 1, Male, healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 23 Apr 2019 (actual)
Primary completion: 5 Jul 2019 (actual)
Study completion: 5 Jul 2019 (actual)
First posted: 29 Apr 2019 (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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Period A	Experimental	Drug: 14C-PF-06651600Single oral dose of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF 06651600).
Period B	Experimental	Drug: 14C-PF-06651600 IV, Drug: PF-06651600Single oral dose of 200 milligrams (mg) unlabeled PF-06651600 followed at time of peak plasma concentration (Tmax) by an Intravenous (IV) dose of 60 micrograms.14C -PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF-06651600).

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Male participants who are healthy as determined by medical evaluation including a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12 lead ECG, and clinical laboratory tests.
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Key exclusion criteria (6 listed)

Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
Infection with hepatitis B or hepatitis C viruses.
Participants with selected acute or chronic infections or infection history.
Participants have a known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.

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
14C-PF-06651600Oral solution of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi radioactivity	Drug	Period A
14C-PF-06651600 IVIV solution 60 micrograms of 14C labeled PF-06651600 containing approximately 300 nCi radioactivity	Drug	Period B
PF-06651600Oral solution 200mg	Drug	Period B

Primary outcome

Mass Balance: Cumulative recovery (%) of radioactivity in urine
Time frame: from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24
Cumulative recovery (%) of radioactivity in urine.
Mass Balance: Cumulative recovery (%) of radioactivity in feces
Time frame: from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24
Cumulative recovery (%) of radioactivity in feces

18 secondary outcomes

Amount (% of the administered dose) of major metabolites of PF-06651600 in plasma
Time frame: Hour 0 up to 312 hours post-dose.
Amount (% of the administered dose) of major metabolites of PF-06651600 in urine
Time frame: Hour 0 up to 312 hours post-dose.
Amount (% of the administered dose) of major metabolites of PF-06651600 in feces
Time frame: Hour 0 up to 312 hours post-dose.
Cmax
Time frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
AUClast
Time frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
AUCinf
Time frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
Tmax
Time frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
t1/2
Time frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
CL (IV)
Time frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
CL/F (oral)
Time frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
Vss
Time frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
Vz/F
Time frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose
Total 14C_Urine_PO
Time frame: Pre-dose, Day1, day 2, day 3, day 4, day 5, day 6 and day 7 post-dose
Total 14C_Urine_IV
Time frame: Pre-dose, Day1, day 2, day 3, day 4, day 5, day 6 and day 7 post-dose
AE
Time frame: Baseline (Day 0) up to 90 days after last dose of study medication
Number of participants with clinically significant changes to the physical examination
Time frame: Baseline (Day 0) up to Day 24
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline (Day 0) up to Day 24
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: Baseline (Day 0) up to Day 24

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 24 Jul 2019.
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

2 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 14C-PF-06651600, 14C-PF-06651600 IV and PF-06651600 in people with Healthy Volunteers, run by Pfizer at 2 sites in Netherlands.

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 2 inclusion and 6 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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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?

Mass Balance: Cumulative recovery (%) of radioactivity in urine (time frame: from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24). 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?

On the ClinicalTrials.gov record for NCT03929510.

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 24 Jul 2019.