HealthyPhase 1NCT01835197
First-in-Human Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of Janus Kinase-1 Inhibitor PF-04965842 in Healthy Western and Japanese Subjects
A Phase 1 study testing PF-04965842 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a Janus kinase1 (JAK1) inhibitor, in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy Western and Japanese subjects. 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-04965842
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2014
- 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/or female subjects between the ages of 18 and 55 years, inclusive.
- Females must be of non-child bearing potential and either at least 1 year post menopausal (FSH ≥40 IU/L), or have documented hysterectomy (with or without bilateral oophrectomy) at least 6 months prior to study day
- Subjects willing to defer receiving prophylactic immunizations (e.g. influenza or pneumococcal vaccines) during the study.
- Absolute lymphocyte count must be greater than or equal to the lower limit of the laboratory reference range.
- Subjects enrolled in Cohort 8 must have four Japanese grandparents born in Japan.
Who cannot join
- Evidence or history of clinically significant hematological, renal, , pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBc Ab) or hepatitis C antibodies (HCV).
- Clinically significant abnormality on chest X-ray performed at screening or within 3 months of screening date; or history of tuberculosis or active or latent or inadequately treated infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Within Cohort, 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-04965842 In Healthy Western and Japanese Subjects
This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a Janus kinase1 (JAK1) inhibitor, in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy Western and Japanese subjects.
- Conditions
- Healthy
- Being tested
- PF-04965842, Placebo
- Keywords
- Phase 1, Randomized, Double Blind, Placebo-Controlled, Single- & Multiple Dose Escalation, Safety, Tolerability, PK, PD, Pf-04965842
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04965842Drug
Subjects will receive single doses of 3, 10, 30, 100, 200, 400, or 800 mg of PF-04695842 (solution or suspension) in a dose escalation format.
PlaceboDrug
Subjects will receive single doses of PF-04695842 matching placebo (solution or suspension) in a dose escalation format.
PF-04965842Drug
Subjects will receive doses of 30, 100 or 200 mg (solution or suspension) once daily for 10 days.
PlaceboDrug
Subjects will receive PF-04965842 matching placebo (solution or suspension) once daily for 10 days.
PF-04965842Drug
Subjects will receive doses of 100 or 200 mg (suspension or solution) twice daily for 10 days.
PlaceboDrug
Subjects will receive PF-04965842 matching placebo doses (suspension or solution) twice daily for 10 days.
PF-04965842Drug
Subjects will receive 200 mg dose (suspension or solution) twice daily for 10 days.
PlaceboDrug
Subjects will receive PF-04965842 matching placebo dose (suspension or solution) twice daily for 10 days.
PF-04965842Drug
Subjects will receive 400 mg dose (suspension or solution) once daily for 10 days.
PlaceboDrug
Subjects will receive PF-04965842 matching placebo dose (suspension or solution) once daily for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1-8 Experimental Arm | Experimental | Not described Receives: Drug: PF-04965842 |
| SAD Cohorts 1-8 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| MAD Cohorts 3 through 5 Experimental Arm | Experimental | Not described Receives: Drug: PF-04965842 |
| MAD Cohorts 3 through 5 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| MAD Cohorts 6 and 7 Experimental Arm | Experimental | Not described Receives: Drug: PF-04965842 |
| MAD Cohorts 6 and 7 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| MAD Cohort 8 Experimental Arm | Experimental | Not described Receives: Drug: PF-04965842 |
| MAD Cohort 8 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| MAD Cohort 9 Experimental Arm | Experimental | Not described Receives: Drug: PF-04965842 |
| MAD Cohort 9 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations
Measured: 6 weeks
Changes from baseline in 12 lead ECG parameters
Quantitative changes in ECG intervals
Measured: 6 weeks
Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events
Measured: 6 weeks
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (with white blood cell count differentials, platelets, PT and aPTT), chemistry, fasting glucose, urinalysis
Measured: 6 weeks
Change from baseline in immunoglobulin levels
Quantitative IgG, IgA, IgM, and IgE levels
Measured: 6 weeks
24-hour urine creatinine clearance (Single Ascending Dose Period)
Measured: Baseline, Day 1
24-hour urine creatinine clearance (Multiple Ascending Dose Period)
Measured: Baseline, Day 1
Secondary outcomes (36)
Complement Level: C3
Measured: 6 weeks
Complement Level: C4
Measured: 6 weeks
Complement Level: C3A
Cohorts 1-7 and Cohort 9
Measured: 6 weeks
Complement Level: Bb
Cohorts 1-7 and Cohort 9
Measured: 6 weeks
Single Ascending Dose: Dose-normalized Area Under the Curve From Time Zero to Infinity (AUCinf(dn))
Measured: 8 days
Multiple Ascending Dose: Accumulation Ratio based on Cmax (Rac(Cmax))
Measured: 6 weeks
Urinary Pharmacokinetics; for twice-a-day dosing, amount of PF-0496842 excreted unchanged in 12 hours (AE12)
Measured: 6 weeks
Urinary Pharmacokinetics; for twice-a-day dosing, percent of PF-0496842 excreted unchanged in 12 hours (AE12%)
Measured: 6 weeks
Multiple Ascending Dose: Apparent Volume of Distribution at Steady State (Vz/F)
Vz/F is the distribution of a drug between plasma and the rest of the body following oral adminstration.
Measured: 6 weeks
Multiple Ascending Dose: Apparent Total Body Clearance (CL/F)
Measured: 6 weeks
Urinary Pharmacokinetics; for once-a-day dosing, amount of PF-0496842 excreted unchanged in 24 hours (AE24)
Measured: 6 weeks
Urinary Pharmacokinetics; for once-a-day dosing, percent of PF-0496842 excreted unchanged in 24 hours (AE24%)
Measured: 6 weeks
Renal Clearance (CLr)
Measured: 6 weeks
High-Sensitivity C-Reactive Protein (hsCRP)
Measured: 6 weeks
Neutrophil counts
Measured: 6 weeks
Reticulocyte counts
Measured: 6 weeks
Complement Level: CH50
Measured: 6 weeks
Single Ascending Dose: Apparent Total Body Clearance (CL/F)
Measured: 8 days
Multiple Ascending Dose: Maximum Observed Plasma Concentration (Cmax)
Measured: 6 weeks
Multiple Ascending Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 6 weeks
Multiple Ascending Dose: Dose-normalized Maximum Observed Plasma Concentration (Cmax(dn))
Measured: 6 weeks
Multiple Ascending Dose: Area Under the Curve to the end of the dosing period (AUCtau(dn))
Measured: 6 weeks
Multiple Ascending Dose: Accumulation Ratio based on AUC predicted (Rss)
Measured: 6 weeks
Multiple Ascending Dose: Accumulation Ration based on AUC observed (Rac)
Measured: 6 weeks
Multiple Ascending Dose: Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.
Measured: 6 weeks
Multiple Ascending Dose: Peak to Trough Fluctuation (PTF)
Measured: 6 weeks
Single Ascending Dose: Dose-normalized Area Under the Curve to the end of the dosing period (AUCtau(dn))
Measured: 8 days
Single Ascending Dose: Area Under the Curve From Time Zero to Infinity (AUCinf)
Measured: 8 days
Single Ascending Dose: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 8 days
Single Ascending Dose: Dose-normalized Maximum Observed Plasma Concentration (Cmax(dn))
Measured: 8 days
Single Ascending Dose: Area Under the Curve to the end of the dosing period (AUCtau)
Measured: 8 days
Single Ascending Dose: Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn))
Dose-normalized area under the plasma concentration time-curve from zero to the last measured concentration (AUClast(dn))
Measured: 8 days
Single Ascending Dose: Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 8 days
Multiple Ascending Dose: Area Under the Curve to the end of the dosing period (AUCtau)
Measured: 6 weeks
Single Ascending Dose: Apparent Volume of Distribution (Vz/F)
Measured: 8 days
Single Ascending Dose: Maximum Observed Plasma Concentration (Cmax)
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 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
- NCT01835197
- Sponsor's protocol ID
- B7451001
- Status last verified
- Jun 2014
- First submitted
- 15 Apr 2013
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
PubMed 35061234Peeva E, Hodge MR, Kieras E, Vazquez ML, Goteti K, Tarabar SG, Alvey CW, Banfield C. Evaluation of a Janus kinase 1 inhibitor, PF-04965842, in healthy subjects: A phase 1, randomized, placebo-controlled, dose-escalation study. Br J Clin Pharmacol. 2018 Aug;84(8):1776-1788. doi: 10.1111/bcp.13612. Epub 2018 May 24.
PubMed 29672897
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Within Cohort, 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-04965842 In Healthy Western and Japanese Subjects
- ClinicalTrials.gov ID
- NCT01835197
- Acronym / sponsor ID
- B7451001
- Conditions
- Healthy
- Keywords
- Phase 1, Randomized, Double Blind, Placebo-Controlled, Single- & Multiple Dose Escalation, Safety, Tolerability, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Apr 2013 (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.
This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a Janus kinase1 (JAK1) inhibitor, in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy Western and Japanese subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1-8 Experimental Arm | Experimental | Drug: PF-04965842 |
| SAD Cohorts 1-8 Placebo Arm | Placebo comparator | Drug: Placebo |
| MAD Cohorts 3 through 5 Experimental Arm | Experimental | Drug: PF-04965842 |
| MAD Cohorts 3 through 5 Placebo Arm | Placebo comparator | Drug: Placebo |
| MAD Cohorts 6 and 7 Experimental Arm | Experimental | Drug: PF-04965842 |
| MAD Cohorts 6 and 7 Placebo Arm | Placebo comparator | Drug: Placebo |
| MAD Cohort 8 Experimental Arm | Experimental | Drug: PF-04965842 |
| MAD Cohort 8 Placebo Arm | Placebo comparator | Drug: Placebo |
| MAD Cohort 9 Experimental Arm | Experimental | Drug: PF-04965842 |
| MAD Cohort 9 Placebo Arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Females must be of non-child bearing potential and either at least 1 year post menopausal (FSH ≥40 IU/L), or have documented hysterectomy (with or without bilateral oophrectomy) at least 6 months prior to study day
- Subjects willing to defer receiving prophylactic immunizations (e.g. influenza or pneumococcal vaccines) during the study.
- Absolute lymphocyte count must be greater than or equal to the lower limit of the laboratory reference range.
- Subjects enrolled in Cohort 8 must have four Japanese grandparents born in Japan.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, , pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBc Ab) or hepatitis C antibodies (HCV).
- Clinically significant abnormality on chest X-ray performed at screening or within 3 months of screening date; or history of tuberculosis or active or latent or inadequately treated infection.
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-04965842Subjects will receive single doses of 3, 10, 30, 100, 200, 400, or 800 mg of PF-04695842 (solution or suspension) in a dose escalation format. | Drug | SAD Cohorts 1-8 Experimental Arm |
| PlaceboSubjects will receive single doses of PF-04695842 matching placebo (solution or suspension) in a dose escalation format. | Drug | SAD Cohorts 1-8 Placebo Arm |
| PF-04965842Subjects will receive doses of 30, 100 or 200 mg (solution or suspension) once daily for 10 days. | Drug | MAD Cohorts 3 through 5 Experimental Arm |
| PlaceboSubjects will receive PF-04965842 matching placebo (solution or suspension) once daily for 10 days. | Drug | MAD Cohorts 3 through 5 Placebo Arm |
| PF-04965842Subjects will receive doses of 100 or 200 mg (suspension or solution) twice daily for 10 days. | Drug | MAD Cohorts 6 and 7 Experimental Arm |
| PlaceboSubjects will receive PF-04965842 matching placebo doses (suspension or solution) twice daily for 10 days. | Drug | MAD Cohorts 6 and 7 Placebo Arm |
| PF-04965842Subjects will receive 200 mg dose (suspension or solution) twice daily for 10 days. | Drug | MAD Cohort 8 Experimental Arm |
| PlaceboSubjects will receive PF-04965842 matching placebo dose (suspension or solution) twice daily for 10 days. | Drug | MAD Cohort 8 Placebo Arm |
| PF-04965842Subjects will receive 400 mg dose (suspension or solution) once daily for 10 days. | Drug | MAD Cohort 9 Experimental Arm |
| PlaceboSubjects will receive PF-04965842 matching placebo dose (suspension or solution) once daily for 10 days. | Drug | MAD Cohort 9 Placebo Arm |
Primary outcome
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations
Time frame: 6 weeks
Changes from baseline in 12 lead ECG parameters
Time frame: 6 weeks
Quantitative changes in ECG intervals
Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events
Time frame: 6 weeks
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (with white blood cell count differentials, platelets, PT and aPTT), chemistry, fasting glucose, urinalysis
Time frame: 6 weeks
Change from baseline in immunoglobulin levels
Time frame: 6 weeks
Quantitative IgG, IgA, IgM, and IgE levels
24-hour urine creatinine clearance (Single Ascending Dose Period)
Time frame: Baseline, Day 1
24-hour urine creatinine clearance (Multiple Ascending Dose Period)
Time frame: Baseline, Day 1
36 secondary outcomes
Complement Level: C3
Time frame: 6 weeks
Complement Level: C4
Time frame: 6 weeks
Complement Level: C3A
Time frame: 6 weeks
Complement Level: Bb
Time frame: 6 weeks
Single Ascending Dose: Dose-normalized Area Under the Curve From Time Zero to Infinity (AUCinf(dn))
Time frame: 8 days
Multiple Ascending Dose: Accumulation Ratio based on Cmax (Rac(Cmax))
Time frame: 6 weeks
Urinary Pharmacokinetics; for twice-a-day dosing, amount of PF-0496842 excreted unchanged in 12 hours (AE12)
Time frame: 6 weeks
Urinary Pharmacokinetics; for twice-a-day dosing, percent of PF-0496842 excreted unchanged in 12 hours (AE12%)
Time frame: 6 weeks
Multiple Ascending Dose: Apparent Volume of Distribution at Steady State (Vz/F)
Time frame: 6 weeks
Multiple Ascending Dose: Apparent Total Body Clearance (CL/F)
Time frame: 6 weeks
Urinary Pharmacokinetics; for once-a-day dosing, amount of PF-0496842 excreted unchanged in 24 hours (AE24)
Time frame: 6 weeks
Urinary Pharmacokinetics; for once-a-day dosing, percent of PF-0496842 excreted unchanged in 24 hours (AE24%)
Time frame: 6 weeks
Renal Clearance (CLr)
Time frame: 6 weeks
High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: 6 weeks
Neutrophil counts
Time frame: 6 weeks
Reticulocyte counts
Time frame: 6 weeks
Complement Level: CH50
Time frame: 6 weeks
Single Ascending Dose: Apparent Total Body Clearance (CL/F)
Time frame: 8 days
Multiple Ascending Dose: Maximum Observed Plasma Concentration (Cmax)
Time frame: 6 weeks
Multiple Ascending Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 6 weeks
Multiple Ascending Dose: Dose-normalized Maximum Observed Plasma Concentration (Cmax(dn))
Time frame: 6 weeks
Multiple Ascending Dose: Area Under the Curve to the end of the dosing period (AUCtau(dn))
Time frame: 6 weeks
Multiple Ascending Dose: Accumulation Ratio based on AUC predicted (Rss)
Time frame: 6 weeks
Multiple Ascending Dose: Accumulation Ration based on AUC observed (Rac)
Time frame: 6 weeks
Multiple Ascending Dose: Plasma Decay Half-Life (t1/2)
Time frame: 6 weeks
Multiple Ascending Dose: Peak to Trough Fluctuation (PTF)
Time frame: 6 weeks
Single Ascending Dose: Dose-normalized Area Under the Curve to the end of the dosing period (AUCtau(dn))
Time frame: 8 days
Single Ascending Dose: Area Under the Curve From Time Zero to Infinity (AUCinf)
Time frame: 8 days
Single Ascending Dose: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 8 days
Single Ascending Dose: Dose-normalized Maximum Observed Plasma Concentration (Cmax(dn))
Time frame: 8 days
Single Ascending Dose: Area Under the Curve to the end of the dosing period (AUCtau)
Time frame: 8 days
Single Ascending Dose: Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn))
Time frame: 8 days
Single Ascending Dose: Plasma Decay Half-Life (t1/2)
Time frame: 8 days
Multiple Ascending Dose: Area Under the Curve to the end of the dosing period (AUCtau)
Time frame: 6 weeks
Single Ascending Dose: Apparent Volume of Distribution (Vz/F)
Time frame: 8 days
Single Ascending Dose: Maximum Observed Plasma Concentration (Cmax)
Time frame: 8 days
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 20 Jun 2014.
- Derived from this study: PubMed 35061234Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
- Derived from this study: PubMed 29672897Peeva E, Hodge MR, Kieras E, Vazquez ML, Goteti K, Tarabar SG, Alvey CW, Banfield C. Evaluation of a Janus kinase 1 inhibitor, PF-04965842, in healthy subjects: A phase 1, randomized, placebo-controlled, dose-escalation study. Br J Clin Pharmacol. 2018 Aug;84(8):1776-1788. doi: 10.1111/bcp.13612. Epub 2018 May 24.
- 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-04965842 in people with Healthy, 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 5 inclusion and 3 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 20 Jun 2014. 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. Some participants in this study may receive a placebo. 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?
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations (time frame: 6 weeks). The study lists 7 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 NCT01835197, which also lists 2 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 20 Jun 2014.