Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 : to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics of SI | Experimental | Cohort 1 is planned to enroll 16-20 healthy adult participants, both male and female |
|
| Cohort 2: to evaluate the effect of CYP3A4 inducer rifampin on the pharmacokinetics of SIM0270. | Experimental | Cohort 2 is planned to enroll 16-20 healthy adult participants, both male and female. |
|
| Cohort 3: to evaluate the effect of SIM0270 on the pharmacokinetics of the CYP3A4 substrate midazol | Experimental | Cohort 3 is planned to enroll 16-20 healthy adult participants,male only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIM0270 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of SIM0270 | To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants. | Day 1-Day 13, Day 16-Day 30 |
| Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270 | To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants. | Day 1-Day 13, Day 16-Day 30 |
| Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270 | To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants. | Day 1-Day 13, Day 16-Day 30 |
| Area under concentration-time curve from time 0 to tau (AUC0-tau) of SIM0270 | To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants. | Day 1-Day 13, Day 16-Day 30 |
| Terminal half-life(t1/2)of SIM0270 | To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants. | Day 1-Day 13, Day 16-Day 30 |
| Maximum observed concentration (Cmax) of SIM0270 | To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants. | Day 1-Day 13, Day 20-Day 32 |
| Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Past/Ongoing Medical History
Surgical history • Those who have undergone major surgery within 6 months prior to screening or are scheduled to undergo surgery during the study and are judged by the investigator to be inappropriate for enrollment.
History of allergy
• Allergic to the study drug or any component of the study drug, with a history of specific allergies (asthma, urticaria, eczema, etc.) or allergic constitution (e.g., those allergic to two or more drugs, food such as milk and pollen).
Medication history
Screening or Baseline Examinations
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiuping Huang, Master | Contact | 86+15060083948 | huangqiuping@zaiming.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong University of Qilu Hospital | Recruiting | Jinan | Shandong | 250100 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| itraconazole | Drug | oral |
|
| Rifampin | Drug | oral |
|
| midazolam | Drug | oral |
|
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants. |
| Day 1-Day 13, Day 20-Day 32 |
| Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270 | To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants | Day 1-Day 13, Day 20-Day 32 |
| Terminal half-life(t1/2)of SIM0270 | To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants. | Day 1-Day 13, Day 20-Day 32 |
| Maximum observed concentration (Cmax) of midazolam | To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants. | Day 1-Day 2, Day 11-Day 13 |
| Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of Midazolam | To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants. | Day 1-Day 2, Day 11-Day 13 |
| Area under concentration-time curve from time 0 to infinity (AUC0-∞) of Midazolam | To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants. | Day 1-Day 2, Day 11-Day 13 |
| Terminal half-life(t1/2)of midazolam | To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants. | Day 1-Day 2, Day 11-Day 13 |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided