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Estimation of the Effect of Multiple Dose Ritlecitinib (PF-06651600) on the Pharmacokinetics of a Single Dose of Caffeine in Healthy Participants

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04655040
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
2.5
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be a Phase 1, 2 period, fixed sequence, multiple-dose, open-label study of the effect of ritlecitinib on caffeine PK in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A PHASE 1, 2-PERIOD, FIXED-SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECTS OF RITLECITINIB (PF-06651600) ON THE PHARMACOKINETICS OF A SINGLE DOSE OF CAFFEINE IN HEALTHY PARTICIPANTS
Actual Study Start Date :
Dec 18, 2020
Actual Primary Completion Date :
Mar 5, 2021
Actual Study Completion Date :
Mar 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Caffeine and Ritlecitinib

In Period 1 Day 1, participants will be dosed with a single oral administration of caffeine 100 milligram (mg) tablet. In Period 2 Day 1 to Day 7, participants will be dosed with a single oral administration of ritlecitinib 200 milligram (mg) tablet. On Day 8, participants will be dosed with caffeine 100 milligram (mg) tablet within 5 minutes after administration of a 200 milligram (mg) dose of ritlecitinib on the morning of Day 8. Dosing with oral 200 milligram (mg) ritlecitinib QD will continue until Day 9.

Drug: Caffeine
100milligram (mg) tablet taken orally in period 1 and period 2

Other: Ritlecitinib
200 milligrams (mg) taken orally once a day(QD) for 8 days
Other Names:
  • PF-06651600

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) of caffeine [Day1 and Day8: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24. Day 8: Hour 36 and 48]

    Secondary Outcome Measures

    1. Incidence of treatment-emergent adverse events [Baseline through Day 28]

    2. Incidence of clinically significant abnormalities in vital signs [Baseline through Day 11]

    3. Incidence of clinically significant abnormalities in clinical laboratory values [Baseline through Day 11]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    -Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.

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

    • Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, 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.

    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, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

    • History of febrile illness within 5 days prior to the first dose of investigational product.

    • History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.

    • Known presence 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.

    • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

    • Participants who, according to the information provided on Drugs.com, would be at increased safety risk if dosed with caffeine.

    • History of hypersensitivity to caffeine.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New Haven Clinical Research Unit New Haven Connecticut United States 06511

    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:
    NCT04655040
    Other Study ID Numbers:
    • B7981054
    First Posted:
    Dec 4, 2020
    Last Update Posted:
    Mar 18, 2021
    Last Verified:
    Mar 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
    Additional relevant MeSH terms:
    Caffeine

    Study Results

    No Results Posted as of Mar 18, 2021