HealthyPhase 1NCT02309827

Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers

A Phase 1 study of Healthy, run by Pfizer at 1 site in Belgium.

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteBelgium
Study dates: Dec 2014to Apr 2016
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Evidence of personally signed and dated informed consent document.
Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
Subjects must avoid high intensity UV light exposure (eg, active sunbathing, tanning beds/booths or sunlamps) from the first dose of study drug and for the duration of the study.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
Screening blood pressure >140/90 mm Hg.
Screening laboratory abnormalities as defined by the protocol.
Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit
Brussels, B-1070

Other trials in Belgium

About this study

Official title: A Phase 1, Randomized, Double Blind, Third-party Open, Placebo-controlled, Single And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06651600 In Healthy Subjects

This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 in healthy volunteers.

Conditions: Healthy
Being tested: PF-06651600 or Placebo
Keywords: Inflammatory bowel disease
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-06651600 or PlaceboDrug
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.

Study groups in NCT02309827
Study group	Role	What they receive
Cohort 1: PF-06651600 or Placebo	Experimental	Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. Receives: Drug: PF-06651600 or Placebo
Cohort 2: PF-06651600 or Placebo	Experimental	Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. Receives: Drug: PF-06651600 or Placebo
Cohort 3: PF-06651600 or Placebo	Experimental	Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. Receives: Drug: PF-06651600 or Placebo
Cohort 4: PF-06651600 or Placebo	Experimental	Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. Receives: Drug: PF-06651600 or Placebo
Cohort 5: PF-06651600 or Placebo	Experimental	Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. Receives: Drug: PF-06651600 or Placebo
Cohort 6: PF-06651600 or Placebo	Experimental	Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. Receives: Drug: PF-06651600 or Placebo
Cohort 7: PF-06651600 or Placebo	Experimental	Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. Receives: Drug: PF-06651600 or Placebo
Cohort 8: PF-06651600 or Placebo	Experimental	Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. Receives: Drug: PF-06651600 or Placebo
Cohort 9: PF-06651600 or Placebo	Experimental	Multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. Receives: Drug: PF-06651600 or Placebo

What is being measured

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

24 hour creatinine clearance (Single Dose)
24 hour urine creatinine clearance in healthy subjects participating in the single dose periods. For the single dose period, assessment occurs on Study Days 0 and 1.
Measured: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
24 hour creatinine clearance (Multiple Dose)
24 hour urine creatinine clearance in healthy subjects participating in the multiple dose period. For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Measured: Multiple dose period, Days 0 (baseline), 7 and 14.
Change from baseline in urine volume (Single Dose)
For the single dose period, assessment occurs on Study Days 0 and 1.
Measured: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
Change from baseline in urine electrolytes (Single Dose)
For the single dose period, assessment occurs on Study Days 0 and 1.
Measured: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
Change from baseline in urine osmolality (Single Dose)
For the single dose period, assessment occurs on Study Days 0 and 1.
Measured: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
Change from baseline of urine volume (Multiple Dose)
For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Measured: Multiple dose period, Days 0 (baseline), 7 and 14.
Change from baseline of urine electrolytes (Multiple Dose)
For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Measured: Multiple dose period, Days 0 (baseline), 7 and 14.
Change from baseline in urine osmolality (Multiple Dose)
For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Measured: Multiple dose period, Days 0 (baseline), 7 and 14.

Secondary outcomes (41)

Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Single Dose)
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Multiple Dose)
Maximum Observed Plasma Concentration (Cmax)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Single Dose)
Time to Reach Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Multiple Dose)
Time to Reach Maximum Observed Plasma Concentration (Cmax)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 (Single Dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600 (Single Dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn) for PF-06651600 (Single Dose)
Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn)
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn) for PF-06651600 (Multiple Dose)
Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinfdn) for PF-06651600 (Single Dose)
Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinfdn)
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastdn) for PF-06651600 (Single Dose)
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastdn)
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06651600 (Single Dose)
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06651600 (Multiple Dose)
Plasma Decay Half-Life (t1/2)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Mean Resonance Time (MRT) for PF-06651600 (Single Dose)
Mean Resonance Time (MRT)
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Mean Resonance Time (MRT) for PF-06651600 (Multiple Dose)
Mean Resonance Time (MRT)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Apparent Volume of Distribution (Vz/F) for PF-06651600 (Single Dose)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06651600 (Multiple Dose)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Apparent Total Body Clearance (CL/F) for PF-06651600 (Single Dose)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent total body clearance (CL/F) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Apparent Total Body Clearance (CL/F) for PF-06651600 (Multiple Dose)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent total body clearance (CL/F) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Minimum Observed Plasma Concentration (Cmin) for PF-06651600 (Multiple Dose)
Minimum Observed Plasma Concentration (Cmin)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Average Concentration for Dosing Interval (12 or 24 hours) (Cav) for PF-06651600 (Multiple Dose)
Average Concentration for Dosing Interval (12 or 24 hours) (Cav)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Area Under the Curve for Dosing Interval (12 or 24 hours) for PF-06651600 (Multiple Dose)
Area Under the Curve for Dosing Interval (12 or 24 hours)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Dose Normalized Area Under the Curve for Dosing Interval (12 or 24 hours) for PF-06651600 (Multiple Dose)
Dose Normalized Area Under the Curve for Dosing Interval (12 or 24 hours)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Peak to Trough Fluctuation (PTF) for PF-06651600 (Multiple Dose)
Peak to Trough Fluctuation (PTF)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Observed Accumulation Ratio (Rac) for PF-06651600 (Multiple Dose)
Observed Accumulation Ratio (Rac)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Observed Accumulation Ratio for Cmax (RacCmax) for PF-06651600 (Multiple Dose)
Observed Accumulation Ratio for Cmax (RacCmax)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Steady State Accumulation Ratio (Rss) for PF-06651600 (Multiple Dose)
Steady State Accumulation Ratio (Rss)
Measured: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Amount of PF-066561600 Excreted Unchanged (Multiple Dose)
Concentration in urine.
Measured: Day 14 (12, 24 hours post dose)
Change from baseline of BCL2 gene expression in whole blood (Single Dose)
Measured: Days -1 and 1 (0, 1, 2, 4, 8, 12 and 24 hours post dose)
Change from baseline of BCL2 gene expression in whole blood (Multiple Dose)
Measured: Days 1, 5, 10, 14 (0, 1, 2, 4, 8, 12 and 24 hours post dose), 16, and 28
Change from baseline of IP-10 protein concentration in serum (Multiple Dose)
Measured: Days 0, 2, 7, 14 (0, and 16 hours post dose) and 16
Change from baseline of hsCRP protein concentration in serum (Multiple Dose)
Measured: Days 0, 2, 7, 14 (0, and 16 hours post dose) and 16
Change from baseline of reticulocyte counts in whole blood (Single Dose)
Measured: Days 0, 2, 3, and 7
Change from baseline of neutrophil counts in whole blood (Single Dose)
Measured: Days 0, 2, 3, and 7
Change from baseline of hemoglobin level whole blood (Single Dose)
Measured: Days 0, 2, 3, and 7
Change from baseline of reticulocyte counts in whole blood (Multiple Dose)
Measured: Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Change from baseline of neutrophil counts in whole blood (Multiple Dose)
Measured: Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Change from baseline of hemoglobin level in whole blood (Multiple Dose)
Measured: Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Renal Clearance (Multiple Dose)
Measured: Day 1, Day 14 (12, 24 hours post dose)
Percentage of PF-066561600 Excreted Unchanged (Multiple Dose)
Concentration in urine.
Measured: Day 14 (12, 24 hours post dose)
Change from baseline of IP-10 gene expression in blood (Multiple Dose)
Measured: Days 0, 5, 10, 14 (0, 1, 2, 4, 8 and 12 hours post dose) and 16
Change from baseline of IP-10 gene expression in blood (Single Dose)
Measured: Days 0, 1 (0, 1, 2, 4, 8 and 12 hours post dose) and 16

Timeline

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

Dec 2014Apr 2016

First posted5 Dec 2014 (estimated)
Study startDec 2014
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Randomised
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02309827
Sponsor's protocol ID: B7981001
Other IDs: 2014-004326-17, PF-06651600, JAK3, 2014
Status last verified: Sep 2016
First submitted: 3 Dec 2014
Last updated: 19 Sep 2016
Results posted: No
Data monitoring committee: No

Publications

Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9.
PubMed 38267790
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
Purohit V, Huh Y, Wojciechowski J, Plotka A, Salts S, Antinew J, Dimitrova A, Nicholas T. Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. AAPS J. 2023 Mar 28;25(3):32. doi: 10.1208/s12248-023-00792-8.
PubMed 36977960
Telliez JB, Dowty ME, Wang L, Jussif J, Lin T, Li L, Moy E, Balbo P, Li W, Zhao Y, Crouse K, Dickinson C, Symanowicz P, Hegen M, Banker ME, Vincent F, Unwalla R, Liang S, Gilbert AM, Brown MF, Hayward M, Montgomery J, Yang X, Bauman J, Trujillo JI, Casimiro-Garcia A, Vajdos FF, Leung L, Geoghegan KF, Quazi A, Xuan D, Jones L, Hett E, Wright K, Clark JD, Thorarensen A. Discovery of a JAK3-Selective Inhibitor: Functional Differentiation of JAK3-Selective Inhibition over pan-JAK or JAK1-Selective Inhibition. ACS Chem Biol. 2016 Dec 16;11(12):3442-3451. doi: 10.1021/acschembio.6b00677. Epub 2016 Nov 10.
PubMed 27791347

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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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double Blind, Third-party Open, Placebo-controlled, Single And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06651600 In Healthy Subjects
ClinicalTrials.gov ID: NCT02309827
Acronym / sponsor ID: B7981001
Conditions: Healthy
Keywords: Inflammatory bowel disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 5 Dec 2014 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Cohort 1: PF-06651600 or Placebo	Experimental	Drug: PF-06651600 or PlaceboSingle ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Cohort 2: PF-06651600 or Placebo	Experimental	Drug: PF-06651600 or PlaceboSingle ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Cohort 3: PF-06651600 or Placebo	Experimental	Drug: PF-06651600 or PlaceboSingle ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Cohort 4: PF-06651600 or Placebo	Experimental	Drug: PF-06651600 or PlaceboSingle ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Cohort 5: PF-06651600 or Placebo	Experimental	Drug: PF-06651600 or PlaceboSingle ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Cohort 6: PF-06651600 or Placebo	Experimental	Drug: PF-06651600 or PlaceboSingle ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Cohort 7: PF-06651600 or Placebo	Experimental	Drug: PF-06651600 or PlaceboSingle ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Cohort 8: PF-06651600 or Placebo	Experimental	Drug: PF-06651600 or PlaceboSingle ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
Cohort 9: PF-06651600 or Placebo	Experimental	Drug: PF-06651600 or PlaceboMultiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Who may qualify

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

Key inclusion criteria (5 listed)

Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Evidence of personally signed and dated informed consent document.
Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
Subjects must avoid high intensity UV light exposure (eg, active sunbathing, tanning beds/booths or sunlamps) from the first dose of study drug and for the duration of the study.

Key exclusion criteria (6 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
Screening blood pressure >140/90 mm Hg.
Screening laboratory abnormalities as defined by the protocol.

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-06651600 or PlaceboPF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.	Drug	Cohort 1: PF-06651600 or Placebo, Cohort 2: PF-06651600 or Placebo, Cohort 3: PF-06651600 or Placebo, Cohort 4: PF-06651600 or Placebo, Cohort 5: PF-06651600 or Placebo, Cohort 6: PF-06651600 or Placebo, Cohort 7: PF-06651600 or Placebo, Cohort 8: PF-06651600 or Placebo, Cohort 9: PF-06651600 or Placebo

Primary outcome

24 hour creatinine clearance (Single Dose)
Time frame: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
24 hour urine creatinine clearance in healthy subjects participating in the single dose periods. For the single dose period, assessment occurs on Study Days 0 and 1.
24 hour creatinine clearance (Multiple Dose)
Time frame: Multiple dose period, Days 0 (baseline), 7 and 14.
24 hour urine creatinine clearance in healthy subjects participating in the multiple dose period. For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Change from baseline in urine volume (Single Dose)
Time frame: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
For the single dose period, assessment occurs on Study Days 0 and 1.
Change from baseline in urine electrolytes (Single Dose)
Time frame: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
For the single dose period, assessment occurs on Study Days 0 and 1.
Change from baseline in urine osmolality (Single Dose)
Time frame: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.
For the single dose period, assessment occurs on Study Days 0 and 1.
Change from baseline of urine volume (Multiple Dose)
Time frame: Multiple dose period, Days 0 (baseline), 7 and 14.
For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Change from baseline of urine electrolytes (Multiple Dose)
Time frame: Multiple dose period, Days 0 (baseline), 7 and 14.
For the multiple ascending dose period assessments occur on Study Days 7 and 14.
Change from baseline in urine osmolality (Multiple Dose)
Time frame: Multiple dose period, Days 0 (baseline), 7 and 14.
For the multiple ascending dose period assessments occur on Study Days 7 and 14.

41 secondary outcomes

Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinfdn) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastdn) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Mean Resonance Time (MRT) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Mean Resonance Time (MRT) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Apparent Volume of Distribution (Vz/F) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Apparent Total Body Clearance (CL/F) for PF-06651600 (Single Dose)
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Apparent Total Body Clearance (CL/F) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Minimum Observed Plasma Concentration (Cmin) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Average Concentration for Dosing Interval (12 or 24 hours) (Cav) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Area Under the Curve for Dosing Interval (12 or 24 hours) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Dose Normalized Area Under the Curve for Dosing Interval (12 or 24 hours) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Peak to Trough Fluctuation (PTF) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Observed Accumulation Ratio (Rac) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Observed Accumulation Ratio for Cmax (RacCmax) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Steady State Accumulation Ratio (Rss) for PF-06651600 (Multiple Dose)
Time frame: Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)
Amount of PF-066561600 Excreted Unchanged (Multiple Dose)
Time frame: Day 14 (12, 24 hours post dose)
Change from baseline of BCL2 gene expression in whole blood (Single Dose)
Time frame: Days -1 and 1 (0, 1, 2, 4, 8, 12 and 24 hours post dose)
Change from baseline of BCL2 gene expression in whole blood (Multiple Dose)
Time frame: Days 1, 5, 10, 14 (0, 1, 2, 4, 8, 12 and 24 hours post dose), 16, and 28
Change from baseline of IP-10 protein concentration in serum (Multiple Dose)
Time frame: Days 0, 2, 7, 14 (0, and 16 hours post dose) and 16
Change from baseline of hsCRP protein concentration in serum (Multiple Dose)
Time frame: Days 0, 2, 7, 14 (0, and 16 hours post dose) and 16
Change from baseline of reticulocyte counts in whole blood (Single Dose)
Time frame: Days 0, 2, 3, and 7
Change from baseline of neutrophil counts in whole blood (Single Dose)
Time frame: Days 0, 2, 3, and 7
Change from baseline of hemoglobin level whole blood (Single Dose)
Time frame: Days 0, 2, 3, and 7
Change from baseline of reticulocyte counts in whole blood (Multiple Dose)
Time frame: Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Change from baseline of neutrophil counts in whole blood (Multiple Dose)
Time frame: Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Change from baseline of hemoglobin level in whole blood (Multiple Dose)
Time frame: Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28
Renal Clearance (Multiple Dose)
Time frame: Day 1, Day 14 (12, 24 hours post dose)
Percentage of PF-066561600 Excreted Unchanged (Multiple Dose)
Time frame: Day 14 (12, 24 hours post dose)
Change from baseline of IP-10 gene expression in blood (Multiple Dose)
Time frame: Days 0, 5, 10, 14 (0, 1, 2, 4, 8 and 12 hours post dose) and 16

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 19 Sep 2016.
Derived from this study: PubMed 38267790Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9.
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.
Derived from this study: PubMed 36977960Purohit V, Huh Y, Wojciechowski J, Plotka A, Salts S, Antinew J, Dimitrova A, Nicholas T. Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. AAPS J. 2023 Mar 28;25(3):32. doi: 10.1208/s12248-023-00792-8.
Derived from this study: PubMed 27791347Telliez JB, Dowty ME, Wang L, Jussif J, Lin T, Li L, Moy E, Balbo P, Li W, Zhao Y, Crouse K, Dickinson C, Symanowicz P, Hegen M, Banker ME, Vincent F, Unwalla R, Liang S, Gilbert AM, Brown MF, Hayward M, Montgomery J, Yang X, Bauman J, Trujillo JI, Casimiro-Garcia A, Vajdos FF, Leung L, Geoghegan KF, Quazi A, Xuan D, Jones L, Hett E, Wright K, Clark JD, Thorarensen A. Discovery of a JAK3-Selective Inhibitor: Functional Differentiation of JAK3-Selective Inhibition over pan-JAK or JAK1-Selective Inhibition. ACS Chem Biol. 2016 Dec 16;11(12):3442-3451. doi: 10.1021/acschembio.6b00677. Epub 2016 Nov 10.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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 of Healthy, run by Pfizer at 1 site in Belgium.

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 5 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 19 Sep 2016. 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 Belgium. 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?

24 hour creatinine clearance (Single Dose) (time frame: Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.). The study lists 8 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 NCT02309827, which also lists 4 linked publications.

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 19 Sep 2016.