Healthy Subjects
Conditions
Brief summary
This is a phase I study to evaluate drug-drug interactions (DDIs) of JAB-21822 as a perpetrator combined with midazolam , rosuvastatin, and digoxin and to evaluate DDIs of JAB-21822 as a victim combined with itraconazole， rifampicin， and omeprazole in healthy subjects.
Interventions
DRUGJAB-21822
JAB-21822 was administered orally
DRUGItraconazole
Itraconazole was administered orally
DRUGOmeprazole
Omeprazole was administered orally
DRUGMidazolam , Rosuvastatin calcium and digoxin
Midazolam , Rosuvastatin calcium and digoxin was administered orally
DRUGRifampicin
Rifampicin was administered orally
Sponsors
Allist Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female ；Healthy subjects aged 18 to 50 years (including both ends) at the time of signing informed consent 2. Male subjects weighed ≥50kg, female subjects weighed ≥45kg, body mass index (BMI) was between 19.0 and 26.0kg/m2, BMI= weight (kg)/height 2 (m2), including boundary values. 3. Subjects voluntarily signed written informed consent and were able to communicate well with the investigator
Exclusion criteria
1. History of severe systemic diseases, history of liver and kidney insufficiency, history of mental illness, history of drug dependence; 2. Patients with a history of interstitial pneumonia, pulmonary fibrosis or other interstitial lung diseases who were not eligible for admission by the investigators; 3. Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, and have digestive diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months before the first dose; 4. The investigator believes that the subject has any other circumstances that make him or her unfit to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed maximum concentrations (Cmax )of JAB-21822 | approximately 10 days |
| Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822 | approximately 10 days |
| Area under the concentration versus time curve from dose to infinity (AUC0-∞) of JAB-21822 | approximately 10 days |
| Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin | approximately 10 days |
| Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of midazolam, rosuvastatin, and digoxin | approximately 10 days |
| Area under the concentration versus time curve from dose to infinity (AUC0-∞) of midazolam, rosuvastatin, and digoxin | approximately 10 days |
Countries
China
Outcome results
None listed