Dermatitis, AtopicPhase 1NCT04065633
Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation
A Phase 1 study testing P3-Fast, Comm-Fast and Vari-Fast in people with Dermatitis, Atopic, run by Pfizer at 1 site in United States.
Trial summary
Part A To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- P3-Fast, Comm-Fast and Vari-Fast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2019to 14 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
Who cannot join
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis
- Evidence or history of clinically significant dermatological condition (eg, atopic dermatitis or psoriasis) .History of tuberculosis (TB) (active or latent) or inadequately treated TB infection.
- History of chronic infections, history of recurrent infections, history of latent infections, .History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
- history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, OPEN LABEL, SINGLE-DOSE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF A COMMERCIAL TABLET FORMULATION OF PF-04965842 RELATIVE TO THE PHASE III TABLET FORMULATION UNDER FASTING CONDITIONS AND THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF THE COMMERCIAL TABLET FORMULATION IN HEALTHY PARTICIPANTS
Part A
- To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions
- To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the variant Phase 3 tablet formulation and the Phase 3 tablet formulation under fasting conditions
- To estimate the effect of food on the amount of study drug in the blood after a single 200 mg dose of the commercial formulation
Read more
Part B
- To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions
Parts A \& B
- To collect samples for genotyping (CYP2C19 and CYP2C9 - enzymes that metabolize [break down] certain medications)
- Genotyping is the collection of a small sample of blood that contains your genes
- To evaluate the safety and tolerability of the study drug after single 200 mg doses of the three different formulations given to healthy participants
- To measure the amount of study drug in the blood after single doses of the different formulations
- To collect exploratory samples for biobanking o Biobanking is the collection and storage of blood samples for possible future testing
Read the detailed description
The purpose of this study in healthy participants is to estimate the bioavailability (BA) of the commercial formulation of PF-04965842 and a variant formulation with slower dissolution relative to the Phase 3 formulation, to demonstrate the bioequivalence (BE) of the commercial formulation relative to the Phase 3 formulation, and to estimate the effect of food on the BA of the commercial formulation. This study consists of 2 parts: Part A is to estimate the relative BA (rBA) of single 200 mg doses of the commercial tablet formulation of PF-04965842 and a variant formulation of slower dissolution rate compared to the Phase 3 tablet formulation. The effect of food on the BA of the commercial tablet formulation will also be evaluated. Part B is to establish BE between the Phase 3 and commercial formulations. The study will follow a staged approach as the sample size for BE cannot be determined with currently available information.
Therefore, it is proposed to assess the maximum observed concentration (Cmax) and area under the curve (AUC) ratios between the Phase 3 and commercial formulations as well as the within-participant variability of Cmax and AUC values determined in Part A. Based on the results from Part A, the sample size of Part B will be determined and the decision to proceed to Part B will be made.
- Conditions
- Dermatitis, Atopic
- Being tested
- P3-Fast, Comm-Fast, Vari-Fast, Comm-Fed
- Keywords
- Phase 1 Bioequivalence Study, Healthy Participants, Estimation of the Effect of Food, Relative Bioavailability
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P3-FastDrug
200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions
Comm-FastDrug
200 mg PF-04965842 commercial tablet formulation under fasted conditions
Vari-FastDrug
200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions
Comm-FedDrug
200 mg PF-04965842 commercial tablet formulation under fed conditions
| Study group | Role | What they receive |
|---|---|---|
| Part A sequence 1 | Experimental | Not described Receives: Drug: P3-Fast; Drug: Comm-Fast; Drug: Vari-Fast; Drug: Comm-Fed |
| Part A sequence 2 | Experimental | Not described Receives: Drug: P3-Fast; Drug: Comm-Fast; Drug: Vari-Fast; Drug: Comm-Fed |
| Part B sequence 1 | Experimental | Not described Receives: Drug: P3-Fast; Drug: Comm-Fast |
| Part B sequence 2 | Experimental | Not described Receives: Drug: P3-Fast; Drug: Comm-Fast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma PF-04965842 PK parameters
AUCinf
Measured: hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post-dose
Plasma PF-04965842 PK parameters
Cmax
Measured: hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post-dose
Secondary outcomes (3)
number of subjects with treatment-emergent adverse event
Measured: baseline until Period 4 study day 35
number of subjects with significant change from baseline in Supine Blood pressure, pulse rate and oral temperature
The actual and the change from baseline values will be summarized by treatment. These data will be listed and out of range values will be summarized
Measured: baseline until Period 4 study day 3
number of subjects with significant Changes from baseline for the ECG parameters QT interval, heart rate, QTc interval, PR
Changes from baseline for the ECG parameters QT interval, heart rate, QTc interval, PR interval, and QRS complex will be summarized by treatment and time. The number (%) of participants with maximum postdose QTc values and maximum increases from baseline in the following categories will be tabulated by treatment
Measured: baseline until Period 4 study day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start18 Jul 2019
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a Phase 1 randomized, open label, single-dose, crossover study in healthy participants to estimate the rBA of the commercial formulation of PF-04965842 (Test formulation 1) and the variant formulation with slower dissolution (Test formulation 2) compared to the Phase 3 formulation (Reference formulation), to demonstrate the BE of the commercial formulation relative to the Phase 3 formulation, and to estimate the effect of food on the rBA of the commercial formulation after a single 200 mg oral dose.
- Masking
- None (open label)
- Enrolment
- 46 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, PfizerSylvester Pawlak, APRN, Principal investigator, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065633
- Sponsor's protocol ID
- B7451032
- Status last verified
- Jan 2020
- First submitted
- 16 Jul 2019
- Last updated
- 7 Jan 2020
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN LABEL, SINGLE-DOSE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF A COMMERCIAL TABLET FORMULATION OF PF-04965842 RELATIVE TO THE PHASE III TABLET FORMULATION UNDER FASTING CONDITIONS AND THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF THE COMMERCIAL TABLET FORMULATION IN HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT04065633
- Acronym / sponsor ID
- B7451032
- Conditions
- Dermatitis, Atopic
- Keywords
- Phase 1 Bioequivalence Study, Healthy Participants, Estimation of the Effect of Food, Relative Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part A
- To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions
- To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the variant Phase 3 tablet formulation and the Phase 3 tablet formulation under fasting conditions
- To estimate the effect of food on the amount of study drug in the blood after a single 200 mg dose of the commercial formulation
Part B
- To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions
Parts A \& B
- To collect samples for genotyping (CYP2C19 and CYP2C9 - enzymes that metabolize [break down] certain medications)
- Genotyping is the collection of a small sample of blood that contains your genes
- To evaluate the safety and tolerability of the study drug after single 200 mg doses of the three different formulations given to healthy participants
- To measure the amount of study drug in the blood after single doses of the different formulations
- To collect exploratory samples for biobanking o Biobanking is the collection and storage of blood samples for possible future testing
Detailed description
The purpose of this study in healthy participants is to estimate the bioavailability (BA) of the commercial formulation of PF-04965842 and a variant formulation with slower dissolution relative to the Phase 3 formulation, to demonstrate the bioequivalence (BE) of the commercial formulation relative to the Phase 3 formulation, and to estimate the effect of food on the BA of the commercial formulation. This study consists of 2 parts: Part A is to estimate the relative BA (rBA) of single 200 mg doses of the commercial tablet formulation of PF-04965842 and a variant formulation of slower dissolution rate compared to the Phase 3 tablet formulation. The effect of food on the BA of the commercial tablet formulation will also be evaluated. Part B is to establish BE between the Phase 3 and commercial formulations. The study will follow a staged approach as the sample size for BE cannot be determined with currently available information.
Therefore, it is proposed to assess the maximum observed concentration (Cmax) and area under the curve (AUC) ratios between the Phase 3 and commercial formulations as well as the within-participant variability of Cmax and AUC values determined in Part A. Based on the results from Part A, the sample size of Part B will be determined and the decision to proceed to Part B will be made.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a Phase 1 randomized, open label, single-dose, crossover study in healthy participants to estimate the rBA of the commercial formulation of PF-04965842 (Test formulation 1) and the variant formulation with slower dissolution (Test formulation 2) compared to the Phase 3 formulation (Reference formulation), to demonstrate the BE of the commercial formulation relative to the Phase 3 formulation, and to estimate the effect of food on the rBA of the commercial formulation after a single 200 mg oral dose.
| Arm | Type | Receives |
|---|---|---|
| Part A sequence 1 | Experimental | Drug: P3-Fast, Drug: Comm-Fast, Drug: Vari-Fast, Drug: Comm-Fed |
| Part A sequence 2 | Experimental | Drug: P3-Fast, Drug: Comm-Fast, Drug: Vari-Fast, Drug: Comm-Fed |
| Part B sequence 1 | Experimental | Drug: P3-Fast, Drug: Comm-Fast |
| Part B sequence 2 | Experimental | Drug: P3-Fast, Drug: Comm-Fast |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
Key exclusion criteria (5 listed)
- Any condition possibly affecting drug absorption (eg, gastrectomy).
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 |
|---|---|---|
| P3-Fast200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions | Drug | Part A sequence 1, Part A sequence 2, Part B sequence 1, Part B sequence 2 |
| Comm-Fast200 mg PF-04965842 commercial tablet formulation under fasted conditions | Drug | Part A sequence 1, Part A sequence 2, Part B sequence 1, Part B sequence 2 |
| Vari-Fast200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions | Drug | Part A sequence 1, Part A sequence 2 |
| Comm-Fed200 mg PF-04965842 commercial tablet formulation under fed conditions | Drug | Part A sequence 1, Part A sequence 2 |
Primary outcome
Plasma PF-04965842 PK parameters
Time frame: hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post-dose
AUCinf
Plasma PF-04965842 PK parameters
Time frame: hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post-dose
Cmax
3 secondary outcomes
number of subjects with treatment-emergent adverse event
Time frame: baseline until Period 4 study day 35
number of subjects with significant change from baseline in Supine Blood pressure, pulse rate and oral temperature
Time frame: baseline until Period 4 study day 3
number of subjects with significant Changes from baseline for the ECG parameters QT interval, heart rate, QTc interval, PR
Time frame: baseline until Period 4 study day 3
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 7 Jan 2020.
- 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
Sylvester Pawlak, APRN principal investigator
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 P3-Fast, Comm-Fast and Vari-Fast in people with Dermatitis, Atopic, run by Pfizer at 1 site 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 1 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 7 Jan 2020. 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 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?
Plasma PF-04965842 PK parameters (time frame: hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 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?
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 7 Jan 2020.