Healthy ParticipantsPhase 1NCT04634565

PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS

A Phase 1 study testing PF-06651600 in people with Healthy Participants, run by Pfizer at 2 sites in China.

Completed

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

Trial summary

This is an open label, single arm study in healthy Chinese male and/or female adult participants. Approximately 9 participants total are planned to participate in this study to ensure that a total of 8 evaluable participants (with all primary PK parameters) can complete the study. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: PF-06651600
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 2 sitesChina
Study dates: 15 Oct 2020to 19 Nov 2020
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Only females of non-childbearing potential
Male and female Chinese participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12 lead ECG.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Body mass index (BMI) of 19 to 27 kg/m2; and a total body weight >50 kg.

Who cannot join

Participants are excluded from the study if any of the following criteria apply:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any condition possibly affecting drug absorption (eg. Gastrectomy, cholecystectomy).
History of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or syphilis; positive testing for HIV, hepatitis B, hepatitis C, and serological reaction of syphilis. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm.
Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.
History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
Previous administration of an investigational drug within 90 days or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).

Trial locations and contacts

2 sites in 1 country.

China2 sites

Peking University Third Hospital
Beijing, Beijing Municipality, 100191
North District of Peking University Third Hospital
Beijing, 100089

Other trials in China

About this study

Official title: A SINGLE CENTER, OPEN LABEL, SINGLE ARM STUDY TO INVESTIGATE THE REPEATED DOSE (FOR 10 DAYS) PHARMACOKINETICS AFTER ORAL ADMINISTRATION OF 200 MG PF-06651600 IN CHINESE HEALTHY ADULT PARTICIPANTS

Conditions: Healthy Participants
Being tested: PF-06651600

What participants receive

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

PF-06651600Drug
oral PF-06651600 tablet 200 mg once daily

Study groups in NCT04634565
Study group	Role	What they receive
PF-06651600	Experimental	PF-06651600 200 milligrams(mg) once daily for 10 days Receives: Drug: PF-06651600

What is being measured

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

Single dose: maximum observed concentration (Cmax)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: time to reach maximum concentration (Tmax)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: area under the concentration-time curve from time 0 to infinity (AUCinf)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: area under the concentration-time curve from time 0 to the time of last quantifiable concentration (AUClast)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: terminal half life (t1/2)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose:AUC24
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: mean residence time (MRT)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: apparent volume of distribution (Vz/F)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: apparent oral clearance (CL/F)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Multiple Dose: Cmax
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: Tmax
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: AUCtau (tau = 24 hours)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: t1/2
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: accumulation ratio on AUCtau (Rac)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: accumulation ratio on Cmax(Rac, Cmax)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: lowest concentration observed during the dosing interval (Cmin)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: average concentration at steady state (Cav)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: MRT
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: apparent volume of distribution at steady state (Vss/F)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: CL/F
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: peak trough fluctuation (PTF)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: peak trough swing (PTS)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: predicted accumulation ratio to estimate linearity (Rss)
Measured: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Measured: From Day1 till Day17
Number of participants with clinically significant change in vital signs from Baseline
Measured: From Day1 till Day17
Number of participants with clinically significant abnormalities in 12-lead electrocardiograms (ECGs)
Measured: From Day1 till Day17
Number of participants with clinically significant abnormalities in physical examination findings
Measured: From Day1 till Day17

Timeline

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

15 Oct 202019 Nov 2020

First posted18 Nov 2020
Study start15 Oct 2020
Primary completion19 Nov 2020
Study completion19 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy ParticipantsStudies 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: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04634565
Sponsor's protocol ID: B7981036
Status last verified: Feb 2021
First submitted: 2 Nov 2020
Last updated: 17 Feb 2021
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.

Publications

Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
PubMed 37917289

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?

See locations

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A SINGLE CENTER, OPEN LABEL, SINGLE ARM STUDY TO INVESTIGATE THE REPEATED DOSE (FOR 10 DAYS) PHARMACOKINETICS AFTER ORAL ADMINISTRATION OF 200 MG PF-06651600 IN CHINESE HEALTHY ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT04634565
Acronym / sponsor ID: B7981036
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 15 Oct 2020 (actual)
Primary completion: 19 Nov 2020 (actual)
Study completion: 19 Nov 2020 (actual)
First posted: 18 Nov 2020 (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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PF-06651600	Experimental	Drug: PF-06651600PF-06651600 200 milligrams(mg) once daily for 10 days

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Only females of non-childbearing potential
Male and female Chinese participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12 lead ECG.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Body mass index (BMI) of 19 to 27 kg/m2; and a total body weight >50 kg.

Key exclusion criteria (8 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any condition possibly affecting drug absorption (eg. Gastrectomy, cholecystectomy).
History of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or syphilis; positive testing for HIV, hepatitis B, hepatitis C, and serological reaction of syphilis. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm.
Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.

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-06651600oral PF-06651600 tablet 200 mg once daily	Drug	PF-06651600

Primary outcome

Single dose: maximum observed concentration (Cmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: time to reach maximum concentration (Tmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: area under the concentration-time curve from time 0 to the time of last quantifiable concentration (AUClast)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: terminal half life (t1/2)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose:AUC24
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: mean residence time (MRT)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: apparent volume of distribution (Vz/F)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: apparent oral clearance (CL/F)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Multiple Dose: Cmax
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: Tmax
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: AUCtau (tau = 24 hours)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: t1/2
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: accumulation ratio on AUCtau (Rac)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: accumulation ratio on Cmax(Rac, Cmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: lowest concentration observed during the dosing interval (Cmin)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: average concentration at steady state (Cav)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: MRT
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: apparent volume of distribution at steady state (Vss/F)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: CL/F
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: peak trough fluctuation (PTF)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: peak trough swing (PTS)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: predicted accumulation ratio to estimate linearity (Rss)
Time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: From Day1 till Day17
Number of participants with clinically significant change in vital signs from Baseline
Time frame: From Day1 till Day17
Number of participants with clinically significant abnormalities in 12-lead electrocardiograms (ECGs)
Time frame: From Day1 till Day17
Number of participants with clinically significant abnormalities in physical examination findings
Time frame: From Day1 till Day17

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 17 Feb 2021.
Derived from this study: PubMed 37917289Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
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.

Related trials for Healthy Participants

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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Not yet recruiting
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RecruitingPhase 1
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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 PF-06651600 in people with Healthy Participants, run by Pfizer at 2 sites in China.

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 8 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 17 Feb 2021. 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 China. 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?

Single dose: maximum observed concentration (Cmax) (time frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1). The study lists 27 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 NCT04634565, which also lists 1 linked publication.

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 17 Feb 2021.