HealthyPhase 1NCT01981681
A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy Subjects
A Phase 1 study testing PF-06263726 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque psoriasis. The goal of the study is to assess the safety, local tolerability, and pharmacokinetics in healthy 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-06263726
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 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 of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects willing to avoid tanning beds and sun exposure of the back during the study.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of application).
- Subjects with any active skin condition at the application site possibly affecting drug absorption (e.g. rash, sun burn, scars, tattoos).
- Subjects with a Draize score >0 of the test area (back) immediately prior to first treatment application.
- Subjects using topical prescription or nonprescription drugs/over the counter preparations on the back within 14 days of the first treatment application.
- Subjects not willing to avoid application of treatmentssuch as lotions or creams to the back throughout the study until follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Third-Party Open, Placebo-Controlled, Multiple Dose Escalation, Parallel Group Study To Evaluate Local Tolerability, Safety And Pharmacokinetics Of Topically Applied PF-06263276 In Healthy Subjects
PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque psoriasis. The goal of the study is to assess the safety, local tolerability, and pharmacokinetics in healthy subjects.
- Conditions
- Healthy
- Being tested
- PF-06263726, Placebo
- Keywords
- Phase 1, Randomized, Placebo-Controlled, Multiple Dose Escalation, Tolerability, Safety, PK, Topical, Healthy, PF-06263276
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06263726Drug
Subjects will receive dose strength of 2% PF-06263276 (1.14 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.
PF-06263726Drug
Subjects will receive dose strength of 4% PF-06263276 (2.28 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.
PF-06263726Drug
Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
PlaceboDrug
Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
PF-06263726Drug
Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
PlaceboDrug
Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Experimental Arm | Experimental | Not described Receives: Drug: PF-06263726 |
| Cohort 2 Experimental Arm | Experimental | Not described Receives: Drug: PF-06263726 |
| Cohort 3 Experimental Arm | Experimental | Not described Receives: Drug: PF-06263726 |
| Cohort 3 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 4 Experimental Arm | Experimental | Not described Receives: Drug: PF-06263726 |
| Cohort 4 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.
Draize toxicity assessment score.
Changes from baseline on Draize toxicity assessment score.
Measured: Day 8, Day 28
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations.
Measured: Day 23, Day 28
Changes from baseline in 12 lead electrocardiogram (ECG) parameters.
Quantitative changes in ECG intervals.
Measured: Day 23, Day 28
Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events.
Measured: Day 23, Day 28
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry, fasting glucose, urinalysis.
Measured: Day 23, Day 28
Secondary outcomes (8)
Cohorts 3 and 4: Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1, Day 14
Cohorts 3 and 4: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Day 1, Day 14
Cohorts 3 and 4: Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Measured: Day 1, Day 14
Cohorts 3 and 4: Dose-Normalized Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Measured: Day 1, Day 14
Cohorts 3 and 4: Dose-Normalized Maximum Observed Plasma Concentration [Cmax (dn)]
Measured: Day 1, Day 14
Cohorts 3 and 4: Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Day 14
Cohorts 3 and 4: Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: Day 14
Cohorts 3 and 4: Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 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
- NCT01981681
- Sponsor's protocol ID
- B5391002
- Other IDs
- 2013-004231-68
- Status last verified
- Jul 2014
- First submitted
- 5 Nov 2013
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Third-Party Open, Placebo-Controlled, Multiple Dose Escalation, Parallel Group Study To Evaluate Local Tolerability, Safety And Pharmacokinetics Of Topically Applied PF-06263276 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01981681
- Acronym / sponsor ID
- B5391002
- Conditions
- Healthy
- Keywords
- Phase 1, Randomized, Placebo-Controlled, Multiple Dose Escalation, Tolerability, Safety, PK, Topical
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Nov 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.
PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque psoriasis. The goal of the study is to assess the safety, local tolerability, and pharmacokinetics in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Experimental Arm | Experimental | Drug: PF-06263726 |
| Cohort 2 Experimental Arm | Experimental | Drug: PF-06263726 |
| Cohort 3 Experimental Arm | Experimental | Drug: PF-06263726 |
| Cohort 3 Placebo Arm | Placebo comparator | Drug: Placebo |
| Cohort 4 Experimental Arm | Experimental | Drug: PF-06263726 |
| Cohort 4 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 (3 listed)
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects willing to avoid tanning beds and sun exposure of the back during the study.
Key exclusion criteria (5 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of application).
- Subjects with any active skin condition at the application site possibly affecting drug absorption (e.g. rash, sun burn, scars, tattoos).
- Subjects with a Draize score >0 of the test area (back) immediately prior to first treatment application.
- Subjects using topical prescription or nonprescription drugs/over the counter preparations on the back within 14 days of the first treatment application.
- Subjects not willing to avoid application of treatmentssuch as lotions or creams to the back throughout the study until follow-up.
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-06263726Subjects will receive dose strength of 2% PF-06263276 (1.14 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back. | Drug | Cohort 1 Experimental Arm |
| PF-06263726Subjects will receive dose strength of 4% PF-06263276 (2.28 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back. | Drug | Cohort 2 Experimental Arm |
| PF-06263726Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back. | Drug | Cohort 3 Experimental Arm |
| PlaceboSubjects will receive dose strength of 2% PF-06263276 (11.4 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back. | Drug | Cohort 3 Placebo Arm |
| PF-06263726Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back. | Drug | Cohort 4 Experimental Arm |
| PlaceboSubjects will receive dose strength of 4% PF-06263276 (22.8 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back. | Drug | Cohort 4 Placebo Arm |
Primary outcome
Draize toxicity assessment score.
Time frame: Day 8, Day 28
Changes from baseline on Draize toxicity assessment score.
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations.
Time frame: Day 23, Day 28
Changes from baseline in 12 lead electrocardiogram (ECG) parameters.
Time frame: Day 23, Day 28
Quantitative changes in ECG intervals.
Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events.
Time frame: Day 23, Day 28
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry, fasting glucose, urinalysis.
Time frame: Day 23, Day 28
8 secondary outcomes
Cohorts 3 and 4: Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1, Day 14
Cohorts 3 and 4: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1, Day 14
Cohorts 3 and 4: Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
Time frame: Day 1, Day 14
Cohorts 3 and 4: Dose-Normalized Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
Time frame: Day 1, Day 14
Cohorts 3 and 4: Dose-Normalized Maximum Observed Plasma Concentration [Cmax (dn)]
Time frame: Day 1, Day 14
Cohorts 3 and 4: Plasma Decay Half-Life (t1/2)
Time frame: Day 14
Cohorts 3 and 4: Apparent Volume of Distribution (Vz/F)
Time frame: Day 14
Cohorts 3 and 4: Apparent Oral Clearance (CL/F)
Time frame: Day 14
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 17 Jul 2014.
- 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-06263726 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 3 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 17 Jul 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 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. 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?
Draize toxicity assessment score. (time frame: Day 8, Day 28). 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?
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 17 Jul 2014.