The purpose of this Phase 1, open-label, 2-arm study is to assess the effect of severe RI on PK, safety, and tolerability of rilzabrutinib compared with normal renal function, in male and female participants aged from 18 to 75 years.
The total duration of the study per participant will be approximately 30 days, including:
* A screening period of up to 27 days. * A 3-day, open-label treatment period, with a single dose on Day 1. * A 1-day follow-up period (Day 3) with an allowable 2-day window (ie, Day 3 to Day 5).
If participants with severe renal impairment: Stable severe chronic kidney disease (no dialysis) assessed by medical history, physical examination, laboratory values.
If participants with normal renal function: Certified as healthy by a comprehensive clinical assessment.
Body weight between 50.0 and 115.0 kg, inclusive, if male, and between 40.0 and 100.0 kg, inclusive, if female, and BMI between 18.0 and 40.0 kg/m2, inclusive, at screening.
Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Regular intake of nicotine more than 10 mg per day and unable to stop smoking during the study (occasional smoker can be enrolled).
History or presence of drug or alcohol abuse.
Uncontrolled cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness, unless the Investigator considers an abnormality to be not clinically significant.
Participants with a history of serious infection requiring intravenous therapy within 4 weeks of study enrollment.
Parallel
rilzabrutinib
DrugPharmaceutical form: Tablet Route of administration: Oral
Rilzabrutinib: AUC
area under the plasma concentration versus time curve
Rilzabrutinib: Cmax
Rilzabrutinib: unbound Cmax
Rilzabrutinib: AUClast
Rilzabrutinib: unbound AUC
This trial is not recruiting at the moment. You can still explore other options:
