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This is a non-randomized, open-label, single-dose, Phase I clinical study and plans to enroll 12-20 healthy elderly subjects aged 65 and above, including 3-6 subjects aged 75 and above, both men and women.
Each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single-dose administration, and ritonavir is administered 12 hours before SIM0417 administration (-12hours), at the time of SIM0417 administration (0hour) and 12hours (12hours), SIM0417 is administered under fasting condition, ritonavir is administered under fasting condition either after meal.
The dose of SIM0417 is 750 mg, and the dose of ritonavir is 100 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIM0417/Ritonavir | Experimental | Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIM0417/Ritonavir | Drug | Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Cmax of SIM0417 | Up to 72 hours from SIM0417 administration |
| AUC0-t | AUC0-t of SIM0417 | Up to 72 hours from SIM0417 administration |
| AUC0-∞ | AUC0-∞ of SIM0417 | Up to 72 hours from SIM0417 administration |
| Tmax | Tmax of SIM0417 | Up to 72 hours from SIM0417 administration |
| t1/2 | t1/2 of SIM0417 | Up to 72 hours from SIM0417 administration |
| CL/F | CL/F of SIM0417 | Up to 72 hours from SIM0417 administration |
| Vz/F | Vz/F of SIM0417 | Up to 72 hours from SIM0417 administration |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Proportion of adverse events | Up to Day 14 |
| Proportion of subjects with abnormal Vital Signs | Proportion of Participants With Clinically Notable Vital Signs |
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Inclusion Criteria:
Exclusion Criteria:
21.Subjects have other conditions that are not suitable for participating in this research, or the subjects may not be able to complete this research for other reasons (judged by the investigator).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Wu | Contact | 18920299268 | wujuan3@simcere.com | |
| Chen Danny | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao | Qianfoshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong First Medical University | Recruiting | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| C000723274 | SIM0417 |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Up to Day 4 |
| Proportion of subjects with abnormal 12-lead electrocardiogram (ECG) | Proportion of Participants With Clinically Notable ECG | Up to Day 4 |
| Proportion of subjects with abnormal Laboratory Tests | Proportion of Participants With Clinically Notable Laboratory Tests | Up to Day 4 |
| Proportion of subjects with abnormal Physical Examination | Proportion of Participants With Clinically Notable Physical Examination | Up to Day 4 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |