Healthy ParticipantsPhase 1NCT04580797

Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations

A Phase 1 study testing PF-06700841 IR, PF-06700841 MR1 and PF-06700841 MR2 in people with Healthy Participants, run by Pfizer at 2 sites in United States.

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 Participants
What is being tested?: PF-06700841 IR, PF-06700841 MR1 and PF-06700841 MR2
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 2 sitesUnited States
Study dates: 2 Oct 2020to 11 Jan 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

Healthy male and female participants between 18 -55 years of age.
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Conditions that affect drug absorption (e.g., gastrectomy cholecystectomy)
History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives)
Positive urine drug test.
History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Quotient Sciences
Coral Gables, Florida, 33134
Quotient Sciences-Miami
Miami, Florida, 33126

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF PF-06700841 FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATIONS UNDER FED AND FASTED CONDITIONS IN PART A AND A RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-06700841 FOLLOWING MULTIPLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATION UNDER FASTED CONDITION IN PART B

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of PF-06700841 following single and multiple oral doses as modified release (MR) formulations in healthy, adult participants under fasted and fed conditions. The objective of Part A is to evaluate the relative bioavailability and food effect of 2 new MR formulations, MR1 and MR2. The objective of Part B is to evaluate the PK and safety/tolerability of MR3 formulation following multiple dose administration over a 7-day period. Overall, results from both parts will facilitate further development of an MR formulation for future clinical studies.

Conditions: Healthy Participants
Being tested: PF-06700841 IR, PF-06700841 MR1, PF-06700841 MR2, PF-06700841 MR3, Placebo

What participants receive

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

PF-06700841 IRDrug
Immediate release formulation
PF-06700841 MR1Drug
Modified release formulation 1
PF-06700841 MR2Drug
Modified release formulation 2
PF-06700841 MR3Drug
Modified release formulation 3
PlaceboOther
Matching placebo

Study groups in NCT04580797
Study group	Role	What they receive
PF-06700841: IR, MR1, MR2, MR1_fed	Experimental	Participants receive single doses of immediate release (IR) followed by modified release (MR) MR1 and MR2, all in fasted condition followed by MR1 in fed condition in Periods 1-4 Receives: Drug: PF-06700841 IR; Drug: PF-06700841 MR1; Drug: PF-06700841 MR2
PF-06700841: MR1, MR2, IR, MR1_fed	Experimental	Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4 Receives: Drug: PF-06700841 IR; Drug: PF-06700841 MR1; Drug: PF-06700841 MR2
PF-06700841: MR2, IR, MR1, MR1_fed	Experimental	Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4 Receives: Drug: PF-06700841 IR; Drug: PF-06700841 MR1; Drug: PF-06700841 MR2
PF-06700841: IR, MR1, MR2, MR2_fed	Experimental	Participants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4 Receives: Drug: PF-06700841 IR; Drug: PF-06700841 MR1; Drug: PF-06700841 MR2
PF-06700841: MR1, MR2, IR, MR2_fed	Experimental	Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4 Receives: Drug: PF-06700841 IR; Drug: PF-06700841 MR1; Drug: PF-06700841 MR2
PF-06700841: MR2, IR, MR1, MR2_fed	Experimental	Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4 Receives: Drug: PF-06700841 IR; Drug: PF-06700841 MR1; Drug: PF-06700841 MR2
PF-06700841 MR3 (Dose A) or matching placebo	Experimental	Participants receive dosing regimen 1 of MR3 (Dose A) or matching placebo for 7 days under fasted condition Receives: Drug: PF-06700841 MR3; Other: Placebo
PF-06700841 MR3 (Dose B) or matching placebo	Experimental	Participants receive dosing regimen 1 of MR3 (Dose B) or matching placebo for 7 days under fasted condition Receives: Drug: PF-06700841 MR3; Other: Placebo
PF-06700841 MR3 (Dose C) or matching placebo	Experimental	Participants receive dosing regimen 1 of MR3 (Dose C) or matching placebo for 7 days under fasted condition Receives: Drug: PF-06700841 MR3; Other: Placebo

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A
Measured: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 in Part A
Measured: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit in Part A
Measured: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part A
Measured: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part B
Measured: Baseline to Day 10

Secondary outcomes (11)

Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A
Measured: Pre-dose and 96 hours post dose
Number of subjects with clinically relevant changes in vital signs in Part A
Measured: Pre-dose and 96 hours post dose
Number of participants with clinically relevant changes in clinical laboratory tests in Part A
Measured: Baseline and 96 hours post dose
Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part A
Measured: Baseline to Day 4
Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 1
Measured: pre-dose, 1,2,3,4,6,8,10,12,16 hours post dose on Day 1
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 1
Measured: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1
Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 7
Measured: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 7
Measured: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7
Area under the plasma concentration-time curve from time zero to 24 hours (AUC24) of PF-06700841 in Part B on Day 1
Measured: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7
Area under the plasma concentration-time curve from time zero to 24 hours (AUCtau) of PF-06700841 in Part B on Day 7
Measured: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7
Terminal half-life of PF-06700841 in Part B
Measured: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7

Timeline

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

2 Oct 202011 Jan 2021

First posted8 Oct 2020
Study start2 Oct 2020
Primary completion11 Jan 2021
Study completion11 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Part A is a partial cross over study with 4 periods; the first three periods are IR, MR1, MR2 in fasted condition and the fourth arm is either MR1 or MR2 in fed condition. Part B is a multiple ascending dose study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04580797
Sponsor's protocol ID: B7931058
Status last verified: Mar 2021
First submitted: 25 Sep 2020
Last updated: 8 Mar 2021
Results posted: 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.

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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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF PF-06700841 FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATIONS UNDER FED AND FASTED CONDITIONS IN PART A AND A RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-06700841 FOLLOWING MULTIPLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATION UNDER FASTED CONDITION IN PART B
ClinicalTrials.gov ID: NCT04580797
Acronym / sponsor ID: B7931058
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 2 Oct 2020 (actual)
Primary completion: 11 Jan 2021 (actual)
Study completion: 11 Jan 2021 (actual)
First posted: 8 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 9
Model description: Part A is a partial cross over study with 4 periods; the first three periods are IR, MR1, MR2 in fasted condition and the fourth arm is either MR1 or MR2 in fed condition. Part B is a multiple ascending dose study

Arm	Type	Receives
PF-06700841: IR, MR1, MR2, MR1_fed	Experimental	Drug: PF-06700841 IR, Drug: PF-06700841 MR1, Drug: PF-06700841 MR2Participants receive single doses of immediate release (IR) followed by modified release (MR) MR1 and MR2, all in fasted condition followed by MR1 in fed condition in Periods 1-4
PF-06700841: MR1, MR2, IR, MR1_fed	Experimental	Drug: PF-06700841 IR, Drug: PF-06700841 MR1, Drug: PF-06700841 MR2Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4
PF-06700841: MR2, IR, MR1, MR1_fed	Experimental	Drug: PF-06700841 IR, Drug: PF-06700841 MR1, Drug: PF-06700841 MR2Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4
PF-06700841: IR, MR1, MR2, MR2_fed	Experimental	Drug: PF-06700841 IR, Drug: PF-06700841 MR1, Drug: PF-06700841 MR2Participants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
PF-06700841: MR1, MR2, IR, MR2_fed	Experimental	Drug: PF-06700841 IR, Drug: PF-06700841 MR1, Drug: PF-06700841 MR2Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4
PF-06700841: MR2, IR, MR1, MR2_fed	Experimental	Drug: PF-06700841 IR, Drug: PF-06700841 MR1, Drug: PF-06700841 MR2Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
PF-06700841 MR3 (Dose A) or matching placebo	Experimental	Drug: PF-06700841 MR3, Other: PlaceboParticipants receive dosing regimen 1 of MR3 (Dose A) or matching placebo for 7 days under fasted condition
PF-06700841 MR3 (Dose B) or matching placebo	Experimental	Drug: PF-06700841 MR3, Other: PlaceboParticipants receive dosing regimen 1 of MR3 (Dose B) or matching placebo for 7 days under fasted condition
PF-06700841 MR3 (Dose C) or matching placebo	Experimental	Drug: PF-06700841 MR3, Other: PlaceboParticipants receive dosing regimen 1 of MR3 (Dose C) or matching placebo for 7 days under fasted condition

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy male and female participants between 18 -55 years of age.
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.

Key exclusion criteria (6 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Conditions that affect drug absorption (e.g., gastrectomy cholecystectomy)
History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives)
Positive urine drug test.
History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.

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-06700841 IRImmediate release formulation	Drug	PF-06700841: IR, MR1, MR2, MR1_fed, PF-06700841: IR, MR1, MR2, MR2_fed, PF-06700841: MR1, MR2, IR, MR1_fed, PF-06700841: MR1, MR2, IR, MR2_fed, PF-06700841: MR2, IR, MR1, MR1_fed, PF-06700841: MR2, IR, MR1, MR2_fed
PF-06700841 MR1Modified release formulation 1	Drug	PF-06700841: IR, MR1, MR2, MR1_fed, PF-06700841: IR, MR1, MR2, MR2_fed, PF-06700841: MR1, MR2, IR, MR1_fed, PF-06700841: MR1, MR2, IR, MR2_fed, PF-06700841: MR2, IR, MR1, MR1_fed, PF-06700841: MR2, IR, MR1, MR2_fed
PF-06700841 MR2Modified release formulation 2	Drug	PF-06700841: IR, MR1, MR2, MR1_fed, PF-06700841: IR, MR1, MR2, MR2_fed, PF-06700841: MR1, MR2, IR, MR1_fed, PF-06700841: MR1, MR2, IR, MR2_fed, PF-06700841: MR2, IR, MR1, MR1_fed, PF-06700841: MR2, IR, MR1, MR2_fed
PF-06700841 MR3Modified release formulation 3	Drug	PF-06700841 MR3 (Dose A) or matching placebo, PF-06700841 MR3 (Dose B) or matching placebo, PF-06700841 MR3 (Dose C) or matching placebo
PlaceboMatching placebo	Other	PF-06700841 MR3 (Dose A) or matching placebo, PF-06700841 MR3 (Dose B) or matching placebo, PF-06700841 MR3 (Dose C) or matching placebo

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A
Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 in Part A
Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit in Part A
Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part A
Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part B
Time frame: Baseline to Day 10

11 secondary outcomes

Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A
Time frame: Pre-dose and 96 hours post dose
Number of subjects with clinically relevant changes in vital signs in Part A
Time frame: Pre-dose and 96 hours post dose
Number of participants with clinically relevant changes in clinical laboratory tests in Part A
Time frame: Baseline and 96 hours post dose
Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part A
Time frame: Baseline to Day 4
Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 1
Time frame: pre-dose, 1,2,3,4,6,8,10,12,16 hours post dose on Day 1
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 1
Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1
Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 7
Time frame: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 7
Time frame: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7
Area under the plasma concentration-time curve from time zero to 24 hours (AUC24) of PF-06700841 in Part B on Day 1
Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7
Area under the plasma concentration-time curve from time zero to 24 hours (AUCtau) of PF-06700841 in Part B on Day 7
Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7
Terminal half-life of PF-06700841 in Part B
Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7

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 8 Mar 2021.
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-06700841 IR, PF-06700841 MR1 and PF-06700841 MR2 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 4 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 8 Mar 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?

Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A (time frame: pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose). The study lists 5 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 NCT04580797.

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 8 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.