Healthy ParticipantsPhase 1NCT04390776
Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.
A Phase 1 study testing PF-06651600 in people with Healthy Participants, run by Pfizer at 2 sites in United States.
Trial summary
The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort. Read more about this study
- Who is it for?
- Ages 18 to 55 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
- 164 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2020to 19 Jul 2021
- 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
- Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and cardiac evaluation (including ECG).
- BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine (including diabetes), pulmonary, gastrointestinal, cardiovascular (including hypertension and congestive heart failure), hepatic, psychiatric, neurological, dermatological, 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).
- Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
- Participants with any of the following acute or chronic infections or infection history:
- Any infection requiring treatment within 2 weeks prior to the dosing visit.
- Any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of study intervention.
Show all 9Show fewer
- Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of study intervention.
- Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
- History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, 55114
About this study
Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE-DOSE STUDY TO EVALUATE THE BIOEQUIVALENCE OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 TO TABLETS AND ESTIMATE THE EFFECT OF HIGH-FAT MEAL ON BIOAVAILABILITY IN HEALTHY PARTICIPANTS
The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.
- 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
PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3). Receives: Drug: PF-06651600 |
| Treatment Sequence 2 | Experimental | PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3). Receives: Drug: PF-06651600 |
| Treatment Sequence 3 | Experimental | PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2). Receives: Drug: PF-06651600 |
| Treatment Sequence 4 | Experimental | PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2). Receives: Drug: PF-06651600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600
Measured: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Maximum plasma PF-06651600 concentration (C max)
Measured: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Secondary outcomes (7)
Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600
Measured: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600
Measured: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose plasma decay half-life (t 1/2) of PF-06651600
Measured: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose Apparent Oral Clearance (CL/F) of PF-06651600
Measured: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600
Measured: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Frequency of abnormal safety laboratory tests
Measured: Baseline up to day 9
Frequency of Adverse Events
Measured: Baseline up to day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start28 Sep 2020
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390776
- Sponsor's protocol ID
- B7981029
- Status last verified
- Aug 2021
- First submitted
- 14 May 2020
- Last updated
- 4 Aug 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
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE-DOSE STUDY TO EVALUATE THE BIOEQUIVALENCE OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 TO TABLETS AND ESTIMATE THE EFFECT OF HIGH-FAT MEAL ON BIOAVAILABILITY IN HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT04390776
- Acronym / sponsor ID
- B7981029
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 18 May 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.
The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: PF-06651600PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3). |
| Treatment Sequence 2 | Experimental | Drug: PF-06651600PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3). |
| Treatment Sequence 3 | Experimental | Drug: PF-06651600PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2). |
| Treatment Sequence 4 | Experimental | Drug: PF-06651600PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and cardiac evaluation (including ECG).
- BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Key exclusion criteria (9 listed)
- Evidence or history of clinically significant hematological, renal, endocrine (including diabetes), pulmonary, gastrointestinal, cardiovascular (including hypertension and congestive heart failure), hepatic, psychiatric, neurological, dermatological, 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).
- Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
- Any infection requiring treatment within 2 weeks prior to the dosing visit.
- Any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of study intervention.
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 100 milligrams (mg) will be provided as Tablets and Capsules. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
Primary outcome
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600
Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Maximum plasma PF-06651600 concentration (C max)
Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
7 secondary outcomes
Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600
Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600
Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose plasma decay half-life (t 1/2) of PF-06651600
Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose Apparent Oral Clearance (CL/F) of PF-06651600
Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600
Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Frequency of abnormal safety laboratory tests
Time frame: Baseline up to day 9
Frequency of Adverse Events
Time frame: Baseline up to day 35
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 4 Aug 2021.
- 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.
- 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 PF-06651600 in people with Healthy Participants, run by Pfizer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 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 4 Aug 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600 (time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.). 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 NCT04390776, 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 4 Aug 2021.