Healthy Subjects
Conditions
Brief summary
This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.
Interventions
DRUGItraconazole
Itraconazole was administered orally
DRUGIBI351
IBI351 was administered orally
DRUGDextromethorphan
Dextromethorphan was administered orally
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol. 2. Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent. 3. Body weight is not less than 50 kg, and body mass index (BMI) is in the range of 19 \ 26 kg/m2 (including both ends). 4. Physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (hepatobiliary, pancreatic, spleen and kidney), echocardiography (only applicable to Cohort 1 subjects) showed no abnormalities; or abnormal test results but judged as normal or clinically insignificant by the investigator.
Exclusion criteria
1. have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication. 2. hepatitis B surface antigen HBsAg positive. 3. hepatitis C virus antibody positive. 4. positive AIDS antigen/antibody or Treponema pallidum antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum concentrations (Cmax ) for IBI351 | approximately 10 days |
| maximum concentrations (Cmax ) for dextromethorphan | approximately 10 days |
| area under the curve from time 0 to infinity(AUC0-inf) for IBI351 | approximately 10 days |
| area under the curve from time 0 to infinity(AUC0-inf) for dextromethorphan | approximately 10 days |
Secondary
| Measure | Time frame |
|---|---|
| apparent clearance (CL/F) for IBI351 | approximately 10 days |
| apparent volume of distribution(Vz/F) for IBI351 | approximately 10 days |
| time-to-maximum concentration (Tmax) for dextromethorphan | approximately 10 days |
| half-life (t1/2) for dextromethorphan | approximately 10 days |
| apparent clearance (CL/F) for dextromethorphan | approximately 10 days |
| apparent volume of distribution(Vz/F) for dextromethorphan | approximately 10 days |
| area under the curve from time 0 to time (AUC0-t) for dextromethorphan | approximately 10 days |
| maximum concentrations (Cmax ) for dextrorphan | approximately 10 days |
| number of participants with abnormal hematology tests | approximately 10 days |
| number of participants with abnormal chemistry parameters | approximately 10 days |
| number of participants with abnormal vital signs | approximately 10 days |
| number of participants with abnormal physical examination findings | approximately 10 days |
| number of participants with abnormal ECG readings | approximately 10 days |
| area under the curve for dextrorphan | approximately 10 days |
| time-to-maximum concentration (Tmax) for IBI351 | approximately 10 days |
| half-life (t1/2) for IBI351 | approximately 10 days |
| area under the curve from time 0 to time (AUC0-t) for IBI351 | approximately 10 days |
Countries
China
Outcome results
None listed