HealthyPhase 1NCT02684760

Bioavailability Study Of PF-06651600 In Healthy Subjects

A Phase 1 study testing PF-06651600 in people with 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.

Trial summary

PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
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: 14 participants
Where: 1 siteBelgium
Study dates: Feb 2016to May 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).
Prior history of chicken pox.
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.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
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, 1070

Other trials in Belgium

About this study

Official title: A Phase 1, Open Label, Single-dose 3-way Crossover Study To Evaluate The Relative Bioavailability Of A Solid Dose Formulation Of Pf-06651600 Under Fasting Conditions And The Effect Of A High Fat Meal On The Bioavailability Of The Solid Dosage Formulation Of Pf-06651600 In Healthy Subjects

Conditions: Healthy
Being tested: PF-06651600
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-06651600Drug
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.

Study groups in NCT02684760
Study group	Role	What they receive
Cohort 1: PF-06651600	Experimental	Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. Receives: Drug: PF-06651600
Cohort 2: PF-06651600	Experimental	Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. Receives: Drug: PF-06651600
Cohort 3: PF-06651600	Experimental	Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. Receives: Drug: PF-06651600
Cohort 4: PF-06651600	Experimental	Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. Receives: Drug: PF-06651600
Cohort 5: PF-06651600	Experimental	Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. Receives: Drug: PF-06651600
Cohort 6: PF-06651600	Experimental	Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. Receives: Drug: PF-06651600

What is being measured

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

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Measured: 0, 0.25, 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
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 0, 0.25, 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
Time to Reach Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

Secondary outcomes (2)

Plasma Decay Half Life (t1/2) for PF-06651600
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Concentration (Tmax) for PF-06651600
Time to Reach Maximum Concentration (Tmax)
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

Timeline

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

Feb 2016May 2016

First posted18 Feb 2016 (estimated)
Study startFeb 2016
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02684760
Sponsor's protocol ID: B7981003
Other IDs: 2015-004857-41, 2015
Status last verified: Jun 2016
First submitted: 12 Feb 2016
Last updated: 16 Jun 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

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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Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open Label, Single-dose 3-way Crossover Study To Evaluate The Relative Bioavailability Of A Solid Dose Formulation Of Pf-06651600 Under Fasting Conditions And The Effect Of A High Fat Meal On The Bioavailability Of The Solid Dosage Formulation Of Pf-06651600 In Healthy Subjects
ClinicalTrials.gov ID: NCT02684760
Acronym / sponsor ID: B7981003
Conditions: Healthy
Keywords: Inflammatory Bowel Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2016
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 18 Feb 2016 (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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Cohort 1: PF-06651600	Experimental	Drug: PF-06651600Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
Cohort 2: PF-06651600	Experimental	Drug: PF-06651600Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
Cohort 3: PF-06651600	Experimental	Drug: PF-06651600Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
Cohort 4: PF-06651600	Experimental	Drug: PF-06651600Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
Cohort 5: PF-06651600	Experimental	Drug: PF-06651600Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
Cohort 6: PF-06651600	Experimental	Drug: PF-06651600Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.

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).
Prior history of chicken pox.
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.

Key exclusion criteria (5 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
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.

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-06651600PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.	Drug	Cohort 1: PF-06651600, Cohort 2: PF-06651600, Cohort 3: PF-06651600, Cohort 4: PF-06651600, Cohort 5: PF-06651600, Cohort 6: PF-06651600

Primary outcome

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600
Time frame: 0, 0.25, 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)
Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Cmax)

2 secondary outcomes

Plasma Decay Half Life (t1/2) for PF-06651600
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Concentration (Tmax) for PF-06651600
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

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 16 Jun 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.
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 testing PF-06651600 in people with 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 5 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 16 Jun 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?

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 (time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose). The study lists 3 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 NCT02684760, which also lists 3 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 16 Jun 2016.