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
Not provided
Not provided
The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: HDM1002 and rifampicin | Experimental | Part 1: Single dose of HDM1002 Part 2: Once daily dose of rifampicin with single dose of HDM1002 |
|
| Cohort 2: HDM1002 and itraconazole | Experimental | Part 1: Single dose of HDM1002 Part 2: Once daily dose of itraconazole with single dose of HDM1002 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM1002 and rifampicin | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC[0-∞] of HDM1002 | Pharmacokinetics (PK) parameter : Area under the curve from time 0 hour to ∞ | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| AUC[0-24 h] of HDM1002 | PK parameter : Area under the curve from time 0 to 24 hour | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| Cmax of HDM1002 | PK parameter : Maximum observed concentration | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| AUC[0-t] of HDM1002 | PK parameters : Area under the curve from time 0 to t hour | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| Tmax of HDM1002 | PK parameters : Time to maximum plasma concentration | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| t1/2 of HDM1002 | PK parameters : Half life | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| CL/F of HDM1002 | PK parameters : Apparent Clearance | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC[0-∞] of HDM1002 metabolites | PK parameters : Area under the curve from time 0 hour to ∞ | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| AUC[0-24 h] of HDM1002 metabolites |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei hu | Contact | 0551-65997164 | hwgcp@ayefy.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second hospital of anhui medical university | Hefei | Anhui | China |
Not provided
| ID | Term |
|---|---|
| D012293 | Rifampin |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HDM1002 and itraconazole |
| Drug |
Administered orally |
|
| Vz/F of HDM1002 |
PK parameters : Apparent volume of distribution |
| Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
PK parameters : Area under the curve from time 0 to 24 hour
| Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| Cmax of HDM1002 metabolites | PK parameters : Maximum observed concentration | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| AUC[0-t] of HDM1002 metabolites | PK parameters : Area under the curve from time 0 to t hour | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| Tmax of HDM1002 metabolites | PK parameters : Time to maximum plasma concentration | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| t1/2 of HDM1002 metabolites | PK parameters: Half life | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| CL/F of HDM1002 metabolites | PK parameters : Apparent Clearance | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| Vz/F of HDM1002 metabolites | PK parameters : Apparent volume of distribution | Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13 |
| Adverse events (AEs) | Number of subjects reporting AEs | Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13 |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |