Healthy
Conditions
Brief summary
This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole
Interventions
DRUGSHR8554；Itraconazole
Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female subjects, aged 18 to 45 years (inclusive). 2. Female subjects body weight≥45 kg, male subjects body weight≥50 kg, body mass index (BMI) of 19.0 to 26.0 kg/m2 (inclusive). 3. Understand the study procedures in the informed consent form and be willing and able to comply with the protocol.
Exclusion criteria
1. Subjects with a history of drug allergy, or a history of specific allergies, or known allergy to SHR8554 or itraconazole or similar. 2. Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study as determined by the investigator. 3. Subjects with positive tests for infectious diseases. 4. Subjects who have undergone major surgery within 3 months prior to screening or have undergone surgery that could significantly affect the in vivo course or safety evaluation of the study drug. 5. History of using any medication within 2 weeks prior to the first dosing. 6. Subjects who have received vaccination within 1 month prior to screening or plan to receive vaccination during the trial. 7. Excessive daily consumption of tea, coffee, grapefruit/grapefruit juice and other special diets in the 1 month prior to screening. 8. Subjects with a history of substance abuse, drug use or a positive screening test for substance abuse. 9. Female who are pregnant or breastfeeding, or have a positive pregnancy test. 10. Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRT0-∞：mean residence time from time 0 to infinity | Day 1 and Day 9 (pre-dose up to 48 hours post-dose) |
| AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration | Day 1 and Day 9 (pre-dose up to 48 hours post-dose) |
| AUC0-∞：area under the plasma concentration-time curve from time 0 to infinity | Day 1 and Day 9 (pre-dose up to 48 hours post-dose) |
| Tmax：observed time to reach Cmax | Day 1 and Day 9 (pre-dose up to 48 hours post-dose) |
| Vz ：apparent volume of distribution | Day 1 and Day 9 (pre-dose up to 48 hours post-dose) |
| Cmax：observed maximum plasma concentration | Day 1 and Day 9 (pre-dose up to 48 hours post-dose) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of participants with clinical laboratory abnormalities | Baseline up to Day 18 |
| Incidence of participants with vital signs abnormalities | Baseline up to Day 18 |
| Incidence of participants with physical exam abnormalities | Baseline up to Day 18 |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Baseline up to Day 18 |
Countries
China
Outcome results
None listed