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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06651600; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): November 22, 2017

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: B7981008; 2017-001298-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No