PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS

NCT04634565 | Completed Phase 1 FDA Drug

• 1 other identifier: B7981036
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open label, single arm study in healthy Chinese male and/or female adult participants. Approximately 9 participants total are planned to participate in this study to ensure that a total of 8 evaluable participants (with all primary PK parameters) can complete the study.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (27)

• Single dose: maximum observed concentration (Cmax)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1

• Single dose: time to reach maximum concentration (Tmax)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1

• Single dose: area under the concentration-time curve from time 0 to infinity (AUCinf)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1

• Single dose: area under the concentration-time curve from time 0 to the time of last quantifiable concentration (AUClast)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1

• Single dose: terminal half life (t1/2)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1

• Single dose:AUC24

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1

• Single dose: mean residence time (MRT)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1

• Single dose: apparent volume of distribution (Vz/F)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1

• Single dose: apparent oral clearance (CL/F)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1

• Multiple Dose: Cmax

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: Tmax

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: AUCtau (tau = 24 hours)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: t1/2

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: accumulation ratio on AUCtau (Rac)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: accumulation ratio on Cmax(Rac, Cmax)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: lowest concentration observed during the dosing interval (Cmin)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: average concentration at steady state (Cav)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: MRT

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: apparent volume of distribution at steady state (Vss/F)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: CL/F

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: peak trough fluctuation (PTF)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: peak trough swing (PTS)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Multiple Dose: predicted accumulation ratio to estimate linearity (Rss)

  0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

  From Day1 till Day17

• Number of participants with clinically significant change in vital signs from Baseline

  From Day1 till Day17

• Number of participants with clinically significant abnormalities in 12-lead electrocardiograms (ECGs)

  From Day1 till Day17

• Number of participants with clinically significant abnormalities in physical examination findings

  From Day1 till Day17

Study Arms (1)

PF-06651600

EXPERIMENTAL

PF-06651600 200 milligrams(mg) once daily for 10 days

Drug: PF-06651600

Interventions

PF-06651600 DRUG

oral PF-06651600 tablet 200 mg once daily

PF-06651600

Eligibility Criteria

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

You may qualify if:

• Only females of non-childbearing potential
• Male and female Chinese participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12 lead ECG.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Body mass index (BMI) of 19 to 27 kg/m2; and a total body weight \>50 kg.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, 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, hepatitis C, or syphilis; positive testing for HIV, hepatitis B, hepatitis C, and serological reaction of syphilis. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm.
• Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
• 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.
• Previous administration of an investigational drug within 90 days or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

North District of Peking University Third Hospital

Beijing, 100089, China

Location

Related Publications (1)

• Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.

  PMID: 37917289 DERIVED

Related Links

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

MeSH Terms

Interventions

PF-06651600

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 18, 2020
• Study Start: October 15, 2020
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)