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| Name | Class |
|---|---|
| Zhejiang Hangyu Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a single-center, non-randomized, open-label, self-controlled, Phase I clinical trial to evaluate the drug-drug interactions (DDI) of JMKX003142 tablets in healthy adult participants.
The study consists of five cohorts (Cohorts 1, 2, 3, 4, and 5). A total of 24 participants are planned enrollment in each of Cohorts 1, 2, 3, and 5, while 16 participants are planned for Cohort 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142 | Experimental |
| |
| Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates | Experimental |
| |
| Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142 | Experimental |
| |
| Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142 | Experimental |
| |
| Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX003142 tablets | Drug | 3mg once daily (QD) on Day 1 and Day 7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites | for 120 hours | |
| Area Under Curve (AUC) of JMKX003142 and its metabolites | for 120 hours | |
| Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites | for 144 hours | |
| Area Under Curve (AUC) of of Midazolam and its metabolites | for 144 hours | |
| Maximum Plasma Concentration (Cmax) of Rosuvastatin | 144 hours | |
| Area Under Curve (AUC) of of Rosuvastatin | for 144 hours | |
| Maximum Plasma Concentration (Cmax) of Digoxin | for 144 hours | |
| Area Under Curve (AUC) of Digoxin | for 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of JMKX003142 and its metabolites | for 120 hours | |
| T1/2 of JMKX003142 and its metabolites | for 120 hours | |
| CL of JMKX003142 and its metabolites |
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Inclusion Criteria:
Exclusion Criteria:
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| Fluconazole Capsules | Drug | 400mg QD on Day 4, 200mg QD from Day 5 to Day 9 |
|
| Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets) | Drug | Midazolam Oral Solution 2mg, Rosuvastatin Calcium Tablets 5mg and Digoxin Tablets 0.25mg QD on Day 1, Day 8 and Day 21 |
|
| Cyclosporine Soft Capsules | Drug | 100 mg twice daily (BID) from Day 4 to Day 9 |
|
| Omeprazole Enteric-coated Tablets | Drug | 40mg QD from Day 4 to Day 8 |
|
| Efavirenz Tablets | Drug | 600mg QD from Day 4 to Day 12 |
|
| JMKX003142 tablets | Drug | 6mg QD from Day 8 to Day 25 |
|
| JMKX003142 tablets | Drug | 6mg QD on Day 1 and Day 8 |
|
| JMKX003142 tablets | Drug | 6mg QD on Day 1 and Day 10 |
|
| for 120 hours |
| Tmax of Midazolam and its metabolites | for 144 hours |
| T1/2 of Midazolam and its metabolites | for 144 hours |
| CL of Midazolam and its metabolites | for 144 hours |
| Tmax of Rosuvastatin | for 144 hours |
| T1/2 of Rosuvastatin | for 144 hours |
| CL of Rosuvastatin | for 144 hours |
| Tmax of Digoxin | for 144 hours |
| T1/2 of Digoxin | for 144 hours |
| CL of Digoxin | for 144 hours |
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| D008874 | Midazolam |
| D004077 | Digoxin |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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