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A Phase 1 Study Evaluating Relative Bioavailability of Sprinkled Ritlecitinib in Applesauce, Yoghurt, and Strawberry Jam and Evaluating the Effect of Food on the Bioavailability of Ritlecitinib Intact Blend-In Capsule in Healthy Adult Participants.
EU CTIS ID: 2022-502872-22-00
What this study is testing
To estimate the relative BA of ritlecitinib intact BiC (Blend in Capsule) when sprinkled on food (apple sauce, strawberry jam, and yoghurt) compared to intact BiC (reference) at a 30 mg dose under fasted conditions in adult healthy participants and to estimate the effect of food on the relative BA of ritlecitinib intact BiC at a 30 mg dose.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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 febrile illness within 5 days prior to the first dose of study intervention.
See the full eligibility criteria
- 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.
- 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 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.
- Evidence of untreated or inadequately treated active or latent Mycobacterium TB infection.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.