A Sub Study to Learn About the Study Medication Called Etrasimod Tablets in a Hybrid Decentralized Clinical Trial Setting
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 2023-508119-22-00
- Record updated
- 2024. március 27.
- Original description
To compare the PK of etrasimod 2 mg clinical IR tablets under fasted conditions in healthy participants using Tasso PK micro samples taken by participants only (Treatment G) vs. CRU staff and participants (Treatment F) in a hybrid DCT designRead full original descriptionShow less
C5041050 - A Phase 1, Open-Label, Single Dose, Fixed-Sequence Crossover Sub Study to Determine the Pharmacokinetics Using Tasso Device and Safety and Tolerability Using Wearable Monitoring Devices Following Single Oral Doses of Etrasimod 2 mg IR Tablets in Healthy Adult Participants in a Hybrid Decentralized Clinical Trial Design
To compare the PK of etrasimod 2 mg clinical IR tablets under fasted conditions in healthy participants using Tasso PK micro samples taken by participants only (Treatment G) vs. CRU staff and participants (Treatment F) in a hybrid DCT design
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 a detailed medical history, full physical exam, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, temperature, and 12-lead ECG; Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg (110 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, anaphylactic, ophthalmologic disorder (such as macular edema, uveitis, retinopathy), or allergic disease; Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy); Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (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 Epstein-Barr virus (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 tuberculosis (TB) infection.