IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
This study is not yet open for participant recruitment.
Verified July 2017 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT03210961
First received: July 3, 2017
Last updated: July 5, 2017
Last verified: July 2017
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: PF-06826647 tablet Drug: PF-06826647 oral suspension Other: Placebo oral solution/suspension Other: Placebo tablet | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: Combination single and multiple ascending dose design. Cohorts of participants are assigned to receive interventions based on acceptable safety, tolerability, and pharmacokinetics of previous dose cohort Masking: Participant, Care Provider, Investigator, Outcomes AssessorMasking Description: Double blind treatment Primary Purpose: Treatment |
| 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-06826647 In Healthy Subjects And Subjects With Plaque Psoriasis |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) up to study day 28 for healthy participants ]
- Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Baseline up to study day 28 for healthy participants ]Clinical laboratory assessments include: including hematology, fibrinogen, chemistry, fasting glucose, lipids, urinalysis
- Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: Baseline up to study day 28 for healthy participants ]Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30change<60 or >=60 msec from baseline.
- Number of Participants With Categorical Vital Signs Data [ Time Frame: Baseline up to study day 28 for healthy participants ]
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) baseline up to study day 84 for psoriasis participants ]
- Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Baseline up to study day 56 for psoriasis participants ]Clinical laboratory assessments include: including hematology, fibrinogen, chemistry, fasting glucose, lipids, urinalysis
- Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: Baseline up to study day 56 for psoriasis participants ]Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30change<60 or >=60 msec from baseline.
- Number of Participants With Categorical Vital Signs Data [ Time Frame: Baseline up to study day 56 for psoriasis participants ]
Secondary Outcome Measures:
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose ]Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose ]Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose ]Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)
- Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post- ]Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)
- Dose Normalized Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose ]Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)
- Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose ]Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)
- Dose Normalized Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Dose Normalized Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants
- Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants
- Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose ]Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)
- Plasma Decay Half-Life (t1/2) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Plasma Decay Half-Life (t1/2) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants
- Apparent Volume of Distribution (Vz/F) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose ]Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)
- Apparent Volume of Distribution (Vz/F) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Apparent Volume of Distribution (Vz/F) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants
- Mean residence time [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose ]Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)
- Mean residence time [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Mean residence time [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants
- Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants
- Average Plasma Concentration [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Average Plasma Concentration [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants
- Observed Accumulation Ratio (Rac) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Observed Accumulation Ratio for Cmax (Rac Cmax) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Peak to Trough Ratio [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose ]Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)
- Peak to Trough Ratio [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants
- Change from baseline in psoriasis area and severity index(PASI)score at Day28 [ Time Frame: Change from baseline at study day 28 ]PASI will be performed in psoriasis participants only
| Estimated Enrollment: | 90 |
| Anticipated Study Start Date: | July 20, 2017 |
| Estimated Study Completion Date: | August 18, 2018 |
| Estimated Primary Completion Date: | August 18, 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-06826647 tablet |
Drug: PF-06826647 tablet
PF-06826647 tablet for oral administration
|
| Placebo Comparator: Placebo tablet |
Other: Placebo tablet
Matching placebo tablet
|
| Experimental: PF-06826647 oral suspension |
Drug: PF-06826647 oral suspension
PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)
|
| Placebo Comparator: Placebo oral solution/suspension |
Other: Placebo oral solution/suspension
placebo oral solution for the single ascending dose, first cohort only
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Healthy Participants:
Inclusion Criteria:
- Healthy male subjects between ages of 18-55 years
- Healthy female subjects of non-childbearing potential between the ages of 18-55 years
- Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs).
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Exclusion Criteria:
- 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 dosing)
- Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential
- Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28days after the last dose of investigational product
- Have a clinically significant infection currently or within 6 months of first dose of study drug
Psoriasis Participants:
Inclusion
- Healthy male subjects between ages of 18-65 years
- Healthy female subjects of non-childbearing potential between the ages of 18-65 years
- Have a diagnosis of plaque psoriasis for at least 6months prior to first study dose
- Have plaque-type psoriasis covering at least 15% of total body surface area (BSA) at Day-1(prior to randomization in the study
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) Exclusion
- Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis
- Have a clinically significant infection currently or within 6 months of first dose of study drug, or a history of chronic or recurrent infectious disease
- Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential
- Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28days after the last dose of investigational product
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03210961
Please refer to this study by its ClinicalTrials.gov identifier: NCT03210961
Contacts
| Contact: Peter Pfizer CT.gov Call Center, Winkle | 1-800-718-1021 | pwinkle@agmg.com |
Sponsors and Collaborators
Pfizer
Investigators
| Principal Investigator: | Peter Winkle, MD | Anaheim Clinical Trials |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT03210961 History of Changes |
| Other Study ID Numbers: |
C2501001 |
| Study First Received: | July 3, 2017 |
| Last Updated: | July 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Pharmaceutical Solutions |
ClinicalTrials.gov processed this record on July 11, 2017