Immune system diseases
Conditions
Interventions
Rilzabrutinib:a single dose of rilzabrutinib in the morning on Day 1 following overnight (=10 hour) fast
Sponsors
XUZHOU CENTEAL HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: - Healthy Chinese male and/or female adults, between 18 and 45 years of age, inclusive. - Laboratory parameters within the normal range (or defined screening threshold for the Investigator site). - Body mass index (BMI) =19.0 and =26.0 (kg/m2), inclusive, and a minimum body weight of 45 kg for female, and 50 kg for male. - Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study. - Willing to abstain from using tobacco or nicotine-containing products from check-in (Day -1) through the Follow-up phone call on Day 5±1 day. - Willing to abstain from consuming alcohol, or taking any prescription drugs, dietary supplements or non-prescription drugs (unless approved by the Investigator) from check-in (Day -1) through the Follow-up phone call on Day 5±1 day. - All contraceptive used by male and female subjects should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.- For females of reproductive potential: negative serum or urine pregnancy test at screening and check-in (Day -1). - Negative drug (including tetrahydrocannabinol, methylenedioxymethamphetamine [MDMA], morphine, ketamine and methamphetamines), and alcohol testing at screening and check-in (Day -1). Screening drug/alcohol testing may be repeated once if deemed appropriate by the site Investigator. - Willing to comply with personal protective equipment (PPE) and social distancing requirements according to local regulations for coronavirus disease 2019 (COVID-19) prevention.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Symptoms consistent with COVID-19 such as fever, cough, and shortness of breath or confirmed infection of COVID-19 by appropriate laboratory test within 4 weeks before Day 1. Subject who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation [ECMO], mechanically ventilated). - Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within the 14 days or 5 half-lives, whichever is longer, prior to the first study drug administration; any biologics (antibody or its derivatives) given within 4 months before inclusion. Use of hormonal contraception is allowed prior to and during the study. - Consumption of products containing grapefruit, star fruit, or Seville orange fruit or juice within 5 days prior to the study drug administration. - Excessive consumption of caffeine or beverages containing xanthine bases (more than 4 cups or glasses per day). - Positive testing for human immunodeficiency virus antibody (HIV-Ab), hepatitis B virus surface antigen (HBsAg) or core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab).. - Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled).. - History or presence of alcohol or drug abuse within 2 years prior to the study drug administration. - History of any significant (as determined by the Investigator) drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, urticaria or multiple drug allergies. - Blood donation or significant blood loss within 60 days prior to the study drug administration. - Plasma donation within 14 days prior to the study drug administration. - Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 3 months or 5 half-lives, whichever is longer, prior to the study drug administration. - Surgery within the past three months prior to the study drug administration determined by the Investigator to be clinically relevant. - QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec (males) or >470 msec (females), or 140 or 90 or 100 bpm at screening or check-in (Day -1). At each examination, resting pulse rate measurement may be repeated once to determine eligibility. - Hypersensitivity or history of idiosyncratic reaction to any components or excipients of the investigational formulation. - Regular alcohol consumption >14 units per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine). - Subjects with a history of tuberculosis, regardless of treatment. - Subject is febrile, temperature >37.9°C (assessed at screening and at baseline); or chronic persistent or recurring infection(s) requiring active treatment with antibiotics, antiviral or antifungals within 4 weeks prior to screening visit, or other frequent recurrent infections deemed unacceptable as per Investigator's judgement. - Any history or p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum plasma concentration (Cmax) calculated for total rilzabrutinib;time to maximum plasma concentration (tmax) calculated for total rilzabrutinib;area under the plasma concentration-time curve from zero to the last measurable concentration (AUC0-last) calculated for total rilzabrutinib;area under the plasma concentration-time curve from zero to infinity (AUC0-8) calculated for total rilzabrutinib;terminal elimination phase half-life (t1/2) calculated for total rilzabrutinib;apparent total clearance of drug from plasma after oral administration (CL/F) calculated for total rilzabrutinib; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-lead electrocardiograms (ECGs), vital signs, clinical laboratory tests (hematology, serum chemistry, coagulation, and urinalysis), adverse events (AEs) or serious adverse events (SAEs), and physical examination; | — |
Countries
CHINA
Contacts
Public ContactWei XU
XUZHOU CENTEAL HOSPITAL
Outcome results
None listed