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This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Healthy volunteers |
|
| Cohort 2 | Experimental | Healthy volunteers |
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| Cohort 3 | Experimental | Healthy volunteers |
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| Cohort 4 | Experimental | Healthy volunteers |
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| Cohort 5 | Experimental | Healthy volunteers |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACHN-383 | Drug | Oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin) | 26 days | |
| Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure) | 26 days | |
| Incidence and severity of adverse events | 26 days | |
| Changes from baseline in the QTcF interval | 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789 | 1 day | |
| PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383 | 3 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Cloutier, PharmD | Achaogen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Perth | Australia |
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| ACHN-789 | Drug | Oral dose |
|
| Placebo | Drug | Oral dose |
|
| PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789 | 1 day |
| PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383 | 3 days |
| PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789 | 1 day |
| PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383 | 3 days |
| PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789 | 1 day |
| PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383 | 3 days |
| PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789 | 1 day |
| PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383 | 3 days |
| PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789 | 1 day |
| PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383 | 3 days |
| PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789 | 1 day |
| PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383 | 3 days |
| PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789 | 1 day |
| PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383 | 3 days |
| PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 1 day |
| PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 5 days |
| PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 1 day |
| PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 5 days |
| PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 1 day |
| PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 5 days |
| PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 1 day |
| PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 5 days |
| PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 1 day |
| PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 5 days |
| PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 1 day |
| PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 5 days |
| PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 1 day |
| PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 5 days |
| PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 1 day |
| PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently | 5 days |
| PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal | 6 days |
| PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal | 6 days |
| PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal | 6 days |
| PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal | 6 days |
| PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal | 6 days |
| PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal | 6 days |
| PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal | 6 days |
| PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal | 6 days |
| PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently | 19 days |
| PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently | 19 days |
| PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently | 19 days |
| PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently | 19 days |
| PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently | 19 days |
| PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently | 19 days |
| PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently | 19 days |
| PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently | 19 days |
| PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently | 19 days |
| Urine concentrations of ACHN-789 after single dose administration | 1 day |
| Urine concentrations of ACHN-383 after single-dose administration | 3 days |
| Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently | 1 day |
| Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently | 5 days |
| Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently | 19 days |