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

Pfizer6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-06651600DRUG

PF-06651600 will be administered as tablet

PlaceboDRUG

Matching placebo will be administered as tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Clinical Research Unit

Brussels, Belgium

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs

Time frame: Baseline up to Day 45

Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS interval, QT Interval, QTC Interval, heart rate)

Time frame: Baseline, 1 hour post-dose on Day 1 and 10

Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature)

Time frame: Baseline, Day 1, 10, 12 and 28

Number of Participants With Change From Baseline in Physical Examinations

Time frame: Baseline up to Day 28

Number of Participants With Laboratory Abnormalities

Time frame: Baseline up to Day 28

Secondary Outcomes

Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 1

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10

Data from ClinicalTrials.gov

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