2023-505603-23-00CompletedPhase 1
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.
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 20 Sept 2023
- Start date
- 29 Jan 2024
- Lead sponsor
- Pfizer Inc.
- EU CT number
- 2023-505603-23-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of febrile illness within 5 days prior to the first dose of study intervention.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | Belgium | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.