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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

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
Healthy Participants Drug: Caffeine Other: Ritlecitinib Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : December 18, 2020
Actual Primary Completion Date : March 5, 2021
Actual Study Completion Date : March 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

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 Name: PF-06651600




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: Baseline through Day 28 ]
  2. Incidence of clinically significant abnormalities in vital signs [ Time Frame: Baseline through Day 11 ]
  3. Incidence of clinically significant abnormalities in clinical laboratory values [ Time Frame: Baseline through Day 11 ]


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655040


Locations
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United States, Connecticut
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04655040    
Other Study ID Numbers: B7981054
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents