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
| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purposes of this study is to assess the relationship between renal function and pharmacokinetics of ACHN-490 Injection.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACHN-490 Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACHN-490 Injection | Drug | 7.5 mg/kg single dose administered intravenously over 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Pharmacokinetics | Plasma PK parameters, including area under the curve from time zero to the last quantifiable sample (AUC0-t) and also extrapolated to infinity (AUC0-∞) total clearance (CLT), steady-state volume of distribution (Vss), maximum concentration (Cmax), time to maximum plasma concentration (Tmax), and the terminal-phase half life (t1/2) Urine PK including renal clearance (CLR), fraction of drug excreted in the urine expressed as a percentage of the ACHN-490 dose administered (Ae%), and amount of drug excreted in the urine through 24 hours (Ae0-24) and through 48 hours (Ae0-48). | 0-96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety and tolerability, including adverse events (AEs), and incidence and magnitude of clinically significant changes from baseline in clinical laboratory values (hematology, chemistry, and urinalysis), physical examination, and electrocardiogram (ECG). | Days 1 to 14 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Achaogen, Inc. | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30275092 | Derived | Komirenko AS, Riddle V, Gibbons JA, Van Wart S, Seroogy JD. A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function. Antimicrob Agents Chemother. 2018 Nov 26;62(12):e01128-18. doi: 10.1128/AAC.01128-18. Print 2018 Dec. |
Not provided
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C550938 | plazomicin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |