A Study to Learn How Different Manufactured Products of the Study Medicine Called Ritlecitinib are Taken up Into the Blood in Healthy Adults When Taken on an Empty Stomach or When Taken With a Meal in Healthy Adults.
Key facts
- Where
- Brussels, BelgiumSee the site
- Phase
- 1. fázis
Where in Belgium
- Pfizer Clinical Research UnitBrussels, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer Inc.
- Trial code
- EU 2023-505603-23-00
- Record updated
- 2024. március 25.
- Original description
To determine the PK profile and relative bioavailability of ritlecitinib as 2 MR capsule formulations, MR1 and MR2, relative to solution formulation under fasted conditions in healthy adult participants.Read full original descriptionShow less
B7981086 - A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF RITLECITINIB FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATIONS UNDER FED AND FASTED CONDITIONS
To determine the PK profile and relative bioavailability of ritlecitinib as 2 MR capsule formulations, MR1 and MR2, relative to solution formulation under fasted conditions in healthy adult participants.
Inclusion: Participants aged 18 or older (or the minimal age of consent in accordance with location regulations) at screening; Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, full physical examination (which includes BP and pulse rate measurement), clinical laboratory tests, and 12-lead ECG; BMI of 16 to 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: History of febrile illness within 5 days prior to the first dose of study intervention; Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease; Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy); Known immunodeficiency disorder, including positive serology for HIV, or a first degree relative with a hereditary immunodeficiency; Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm history; Participants with any of the specified acute or chronic infections or infection history; 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.