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Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT05097716
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
2.3
Actual Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1, 2-period, multiple-dose, open-label, single fixed sequence study of the effect of ritlecitinib on tolbutamide pharmacokinetics in healthy participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

A total of approximately 12 healthy male and/or female participants will be enrolled in the study to obtain at least 10 evaluable participants who complete the study. This is an open-label study not requiring an assessment of efficacy or pharmacodynamics markers, but it will include pharmacokinetic estimation drug-drug interactions.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY TO ESTIMATE THE EFFECT OF MULTIPLE-DOSE RITLECITINIB (PF-06651600) ON THE PHARMACOKINETICS OF SINGLE-DOSE TOLBUTAMIDE IN HEALTHY PARTICIPANTS
Actual Study Start Date :
Nov 2, 2021
Actual Primary Completion Date :
Jan 10, 2022
Actual Study Completion Date :
Jan 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ritlecitinib and tolbutamide

In Period 1, participants will be dosed with a single administration of tolbutamide 500 mg tablet on Day 1. Period 1 will be immediately followed by Period 2 with no washout. In Period 2, participants will be dosed with oral 200 mg ritlecitinib QD for 10 days followed by administration of a single dose of 500 mg tolbutamide oral tablet within approximately 5 minutes after administration of a 200 mg dose of ritlecitinib on the morning of Day 10.

Drug: Ritlecitinib
Ritlecitinib 200 mg provided as four 50 mg oral capsules
Other Names:
  • PF-06651600

    • Drug: Tolbutamide
    Tolbutamide 500 mg provided as one 500 mg oral tablet

    Outcome Measures

    Primary Outcome Measures

    1. Cmax of tolbutamide [pre-dose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, and 36 hours post-dose in Periods 1 and 2]

      Maximum plasma concentration

    2. AUCinf (if data permit, otherwise AUClast) of tolbutamide [pre-dose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, and 36 hours post-dose in Periods 1 and 2]

      AUCinf: area under the plasma concentration-time profile from time 0 extrapolated to infinite time; AUClast: area under the plasma concentration-time profile from time 0 to time of the last quantifiable concentration (Clast).

    Secondary Outcome Measures

    1. Incidence of treatment-emergent adverse events [Baseline to day 28]

      Treatment-emergent serious and non-serious adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

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

    Exclusion Criteria:

    • Past/present clinically significant hematological, renal, endocrine, pulmonary, GI, CV, hepatic, psychiatric, neurological, dermatological or allergic disease (including drug allergies).

    • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

    • Infection with hepatitis B or C viruses.

    • Participants with any of the following acute or chronic infections or infection history: any infection requiring treatment within 2 weeks prior to the start of study participation; any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of investigational product; any infection judged to be an opportunistic infection or clinically significant within the past 6 months of the first dose of investigational product; known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections; history of recurrent localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.

    • 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.

    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:
    NCT05097716
    Other Study ID Numbers:
    • B7981069
    • 2021-003611-25
    First Posted:
    Oct 28, 2021
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    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
    Keywords provided by Pfizer
    pharmacokinetics (PK)
    Additional relevant MeSH terms:
    Tolbutamide

    Study Results

    No Results Posted as of Jan 28, 2022