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Completed

NCT Number: NCT04634565

PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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).

Treatment and study plan

PF-06651600

Drug

oral PF-06651600 tablet 200 mg once daily

Primary outcomes

  1. Single dose: maximum observed concentration (Cmax)

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

  2. Single dose: time to reach maximum concentration (Tmax)

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

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

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

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

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

  5. Single dose: terminal half life (t1/2)

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

  6. Single dose:AUC24

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

  7. Single dose: mean residence time (MRT)

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

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

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

  9. Single dose: apparent oral clearance (CL/F)

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

  10. Multiple Dose: Cmax

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

  11. Multiple Dose: Tmax

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

  12. Multiple Dose: AUCtau (tau = 24 hours)

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

  13. Multiple Dose: t1/2

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

  14. Multiple Dose: accumulation ratio on AUCtau (Rac)

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

  15. Multiple Dose: accumulation ratio on Cmax(Rac, Cmax)

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

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

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

  17. Multiple Dose: average concentration at steady state (Cav)

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

  18. Multiple Dose: MRT

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

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

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

  20. Multiple Dose: CL/F

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

  21. Multiple Dose: peak trough fluctuation (PTF)

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

  22. Multiple Dose: peak trough swing (PTS)

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

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

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

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

    Time frame: From Day1 till Day17

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

    Time frame: From Day1 till Day17

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

    Time frame: From Day1 till Day17

  27. Number of participants with clinically significant abnormalities in physical examination findings

    Time frame: From Day1 till Day17

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A SINGLE CENTER, OPEN LABEL, SINGLE ARM STUDY TO INVESTIGATE THE REPEATED DOSE (FOR 10 DAYS) PHARMACOKINETICS AFTER ORAL ADMINISTRATION OF 200 MG PF-06651600 IN CHINESE HEALTHY ADULT PARTICIPANTS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 18, 2020
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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