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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

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ClinicalTrials.gov Identifier: NCT04655040
Recruitment Status : Completed
First Posted : December 4, 2020
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 3, 2020
First Posted Date  ICMJE December 4, 2020
Last Update Posted Date March 18, 2021
Actual Study Start Date  ICMJE December 18, 2020
Actual Primary Completion Date March 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2020)
Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) of caffeine [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2020)
  • Incidence of treatment-emergent adverse events [ Time Frame: Baseline through Day 28 ]
  • Incidence of clinically significant abnormalities in vital signs [ Time Frame: Baseline through Day 11 ]
  • Incidence of clinically significant abnormalities in clinical laboratory values [ Time Frame: Baseline through Day 11 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Estimation of the Effect of Multiple Dose Ritlecitinib (PF-06651600) on the Pharmacokinetics of a Single Dose of Caffeine in Healthy Participants
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • 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 Name: PF-06651600
Study Arms  ICMJE 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.

Interventions:
  • Drug: Caffeine
  • Other: Ritlecitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 5, 2021
Actual Primary Completion Date March 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04655040
Other Study ID Numbers  ICMJE B7981054
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP