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PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04634565
Collaborator
(none)
9
Enrollment
2
Locations
1
Arm
1.1
Actual Duration (Months)
4.5
Patients Per Site
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official 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
Actual Study Start Date :
Oct 15, 2020
Actual Primary Completion Date :
Nov 19, 2020
Actual Study Completion Date :
Nov 19, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: PF-06651600

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

Drug: PF-06651600
oral PF-06651600 tablet 200 mg once daily

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. 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]

  4. 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]

  5. 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]

  6. Single dose:AUC24 [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) [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) [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) [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 [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 [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) [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 [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) [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) [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) [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) [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 [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) [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 [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) [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) [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) [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) [From Day1 till Day17]

  25. Number of participants with clinically significant change in vital signs from Baseline [From Day1 till Day17]

  26. Number of participants with clinically significant abnormalities in 12-lead electrocardiograms (ECGs) [From Day1 till Day17]

  27. Number of participants with clinically significant abnormalities in physical examination findings [From Day1 till Day17]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing Beijing China 100191
2 North District of Peking University Third Hospital Beijing China 100089

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04634565
Other Study ID Numbers:
  • B7981036
First Posted:
Nov 18, 2020
Last Update Posted:
Feb 17, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Feb 17, 2021