Study to Assess Pharmacokinetics, Safety and Tolerability of PF-04965842 in Chinese Healthy Participants

NCT04099563 | Completed Phase 1

• 1 other identifier: B7451028
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmacokinetics, safety and tolerability of PF-04965842 after single dose and once-daily multiple-doses in Chinese healthy participants.

Conditions

HEALTHY

Outcome Measures

Primary Outcomes (4)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

  PK parameters derived from plasma PF-04965842 concentration

  The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1

• Maximum Observed Plasma Concentration (Cmax)

  PK parameters derived from plasma PF-04965842 concentration

  The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  PK parameters derived from plasma PF-04965842 concentration

  The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1

• Area under the plasma concentration time profile from time zero to time tau

  PK parameters derived from plasma PF-04965842 concentration

  The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1 and Day8

Secondary Outcomes (4)

• Number of Participants With Adverse Events (AEs)

  Screening up to follow up (71 days)

• Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests

  Screening up to follow up (71 days)

• Number of Pariticipants With Clinically Significant Change From Baseline in Vital Signs

  Screening up to follow up (71 days)

• Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings

  Screening up to follow up (71 days)

Study Arms (1)

PF-04965842

EXPERIMENTAL

Following an overnight fast for at least 10 hours, participants will receive PF-04965842 oral single dose of 200 mg (2 × 100 mg tablets) on Day 1, at approximately 08:00 am plus or minus 2 hours in the morning. On Days 3 to 8, participants will receive PF-04965842 oral dose of 200 mg (2 × 100 mg tablets) QD in the morning at approximately similar clock hour as on Day 1. On Day 3 and Day 6-8, the dosing of PF-04965842 will be after collection of pre-dose blood samples (under fasted condition for at least 10 hours). On Day 8, the dosing will be under fasted condition at approximately 8:00 am plus or minus 2 hours in the morning.

Drug: PF-04965842

Interventions

PF-04965842 DRUG

For this study, the investigational product is PF-04965842 (provided as 100 mg tablet). PF-04965842 100 mg tablets will be provided by Pfizer. Investigational product will be presented to the participants in individual dosing containers

Also known as: Following an overnight fast for at least 10 hours, participants will receive PF-04965842 oral single dose of 200 mg (2 × 100 mg tablets) on Day 1, at approximately 08:00 am plus or, minus 2 hours in the morning, and repeated doses on Day 3 to 8. On Day 8, the dosing will be under fasted, condition at approximately 8:00 am plus or minus 2 hours in the morning.

PF-04965842

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) of 19 to 26 kg/m2; and a total body weight \>50 kg.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

You may not qualify if:

• Evidence or clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
• History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) and serological reaction of syphilis. As an exception, a positive hepatitis B surface antibody (HBsAb) finding as a result of participant vaccination is permissible.
• Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
• History of tuberculosis (TB) or active or latent or inadequately treated infection, positive QuantiFERON- TB Gold test or positive chest radiographs for active tuberculosis infection.
• Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.
• History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
• Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
• A positive urine drug test.
• Screening sitting blood pressure (BP) \>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is \>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
• Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \>=1.5 × upper limit of normal (ULN); Total bilirubin level \>1 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is \<=1 × ULN.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Beijing Hospital Sub-Center of Beijing Hospital Clinical Trial & Research Center

Beijing, 102200, China

Location

Related Links

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

MeSH Terms

Interventions

abrocitinib; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, single-arm, single- and multiple-dose study

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 23, 2019
• Study Start: October 14, 2019
• Primary Completion: November 9, 2019
• Study Completion: December 9, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)