Status:
COMPLETED
A Study to Learn About Three Forms of The Study Medicine (Ritlecitinib) in Healthy Adults
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare if three forms of study medicine (called ritlecitinib) get processed differently in healthy adults. This study is seeking healthy participants who have: * Age...
Detailed Description
Ritlecitinib is a covalent and irreversible inhibitor of JAK3 with high selectivity over the other JAK isoforms (JAK1, JAK2, and TYK2). Ritlecitinib also inhibits irreversibly the TEC family kinases w...
Eligibility Criteria
Inclusion
- Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- BMI of 16-32 kg/m2, and a total body weight \>45 kg (99 lb).
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Capable of giving signed informed consent
Exclusion
- 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).
- Participants with the acute or chronic infections or infection history
- History of febrile illness within 5 days prior to the first dose of study intervention.
- 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 present or a history of malignancy other than a successfully treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- History of active or latent Mycobacterium TBA: participant who is currently being treated for active or latent Mycobacterium TB infection or has a history of Mycobacterium TB must be excluded from the study.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06172348
Start Date
February 1 2024
End Date
March 28 2024
Last Update
April 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium, B-1070