Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers

Study Overview
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Brief Summary
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This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600 in Japanese healthy volunteers.

Official Title
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A Phase 1, Randomized, Double-blind, Third-party Open, Placebo-controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics After Multiple Oral Doses Of Pf-06651600 In Healthy Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-06651600
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have four Japanese grandparents who were born in Japan. Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) BMI of 17.5 to 27.5 kg/m2; and a total body weight >50 kg (110 lbs). Evidence of personally signed and dated informed consent document. Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. Males of childbearing potential 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 28 days after the last dose of investigational product Use of tobacco/nicotine containing products in excess of 5 cigarettes/day. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males. Screening blood pressure >140/90 mm Hg. Screening laboratory abnormalities as defined by the protocol. Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-06651600<br>Multiple ascending doses of PF-06651600 | Drug: PF-06651600<br>* PF-06651600 will be administered as tablet<br>|
| Placebo Comparator: Placebo<br>Multiple ascending doses of Placebo | Drug: Placebo<br>* Matching placebo will be administered as tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs |  | Baseline up to Day 45 | 
| Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS interval, QT Interval, QTC Interval, heart rate) |  | Baseline, 1 hour post-dose on Day 1 and 10 | 
| Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature) |  | Baseline, Day 1, 10, 12 and 28 | 
| Number of Participants With Change From Baseline in Physical Examinations |  | Baseline up to Day 28 | 
| Number of Participants With Laboratory Abnormalities |  | Baseline up to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 1 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | 
| Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 10 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 1 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 10 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | 
| Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06651600 at Day 1 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06651600 at Day 1 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | 
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 1 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | 
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 10 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | 
| Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 1 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | 
| Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 10 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | 
| Observed Accumulation Ratio (Rac) on AUCtau for PF-06651600 at Day 10 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | 
| Observed Accumulation Ratio on Cmax (RacCmax) for PF-06651600 at Day 10 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 | 
| MinimumObserved Plasma Concentration (Cmin) of PF-06651600 at Day 10 |  | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 |