A Target Occupancy Study With Ritlecitinib.

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05128058
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
2.8
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 1, open label, two-arm study to assess target occupancy and functional inhibition of JAK3 and TEC kinases by Ritlecitinib in healthy adult participants

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Ritlecitinib 50 mg
  • Drug: Ritlecitinib 200 mg
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
AN OPEN LABEL, PHASE 1, TWO-ARM STUDY TO ASSESS TARGET OCCUPANCY AND FUNCTIONAL INHIBITION OF JAK3 AND TEC KINASES BY SINGLE DOSES OF RITLECITINIB IN HEALTHY ADULT PARTICIPANTS
Actual Study Start Date :
Oct 22, 2021
Anticipated Primary Completion Date :
Jan 14, 2022
Anticipated Study Completion Date :
Jan 14, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cohort 1

Subjects will be dosed with 50 mg Ritlecitinib on Day 1 and followed up till Day 3

Drug: Ritlecitinib 50 mg
50 mg single dose
Other Names:
  • PF-06651600
  • Experimental: Cohort 2

    Subjects will be dosed with 200 mg Ritlecitinib on Day 1 and followed up till Day 3

    Drug: Ritlecitinib 200 mg
    200 mg single dose
    Other Names:
  • PF-06651600
  • Outcome Measures

    Primary Outcome Measures

    1. Percent Change from Baseline in Target Occupancy (TO) [Predose, 1 hr, 4 hr, 8 hr, 24 hr, and 48 hr post dose]

      Percent Change from Baseline in TO for Janus Kinase 3 (JAK3) and Tyrosine kinase Expressed in hepatocellular Carcinoma (TEC)

    Secondary Outcome Measures

    1. Maximum Plasma Concentration (Cmax) of Ritlecitinib [Day 1]

      Cmax will be observed directly from data.

    2. Time to Maximum Plasma Concentration (Tmax) of Ritlecitinib [Day 1]

      Tmax will be observed directly from data.

    3. Plasma concentration at 48 hours post-dose (Clast) of Ritlecitinib [48 hours post dose]

      Clast will be observed directly from data.

    4. Average plasma concentration from time 0 to 24 hrs (Cav) of Ritlecitinib [Predose, 1 hr, 2 hr, 4 hr, 8 hr, and 24 hr post dose]

      Calculated as area under the concentration time curve over the dosing frequency

    5. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24) of Ritlecitinib [Predose, 1 hr, 2 hr, 4 hr, 8 hr, 24 hr, and 48 hr post dose]

      Area under the plasma concentration-time curve from time 0 to 24 hours (dosing frequency)

    6. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of Ritlecitinib [Predose, 1 hr, 2 hr, 4 hr, 8 hr, 24 hr, and 48 hr post dose]

      Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (Clast)

    7. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [Baseline (Day 0) up to 28 days after last dose of study drug]

    8. Number of Participants With Change From Baseline in Laboratory Tests Results [Baseline through study completion, approximately 3 days]

    9. Number of Participants With Categorical Vital Signs Data [Baseline through study completion, approximately 3 days]

    10. Number of Adverse Events by Severity [Baseline up to 28 days after last dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Participants are eligible to be included in the study only if all the following criteria apply:

    • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

    • Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination including BP and pulse rate measurement, 12-lead ECG, or clinical and laboratory tests.

    • BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

    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).

    • Infection with hepatitis B or hepatitis C viruses

    • Have evidence of untreated or inadequately treated active or latent Mycobacterium TB infection

    • Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.

    • Have received only one of the 2 required doses of COVID-19 vaccine.

    • Participants have a known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1New Haven Clinical Research UnitNew HavenConnecticutUnited States06511

    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:
    NCT05128058
    Other Study ID Numbers:
    • B7981045
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 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

    Study Results

    No Results Posted as of Nov 19, 2021