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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR8554 and itraconazole | Experimental | SHR8554 will be provided in a solution. Participants will receive 1 mg SHR8554 by intravenous pump on Day 1 and Day 9. Itraconazole capsules 200 mg orally after meals twice daily for 7 days from Day 4 to Day 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR8554ï¼›Itraconazole | Drug | Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax:observed maximum plasma concentration | 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) | |
| MRT0-∞:mean residence time from time 0 to infinity | Day 1 and Day 9 (pre-dose up to 48 hours post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Baseline up to Day 18 | |
| Incidence of participants with clinical laboratory abnormalities | Baseline up to Day 18 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Drum Tower Hospital, Medical School of Nanjing University | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40593123 | Derived | Huang L, Jiang H, Huang Y, Li J. Exploring Pharmacokinetic interactions between SHR8554, a micro-opioid receptor biased agonist, and Itraconazole in healthy Chinese subjects. Sci Rep. 2025 Jul 2;15(1):22635. doi: 10.1038/s41598-025-98697-3. |
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| Incidence of participants with vital signs abnormalities |
| Baseline up to Day 18 |
| Incidence of participants with physical exam abnormalities | Baseline up to Day 18 |