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
Not provided
To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function impairment after single intravenous (IV) infusion of POL7080
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild renal impairment | Experimental | 3h IV POL7080 infusion |
|
| Moderate renal impairment | Experimental | 3h IV POL7080 infusion |
|
| Severe renal impairment | Experimental | 3h IV POL7080 infusion |
|
| End stage renal disease arm 1 | Experimental | 3h IV POL7080 infusion |
|
| End stage renal disease arm 2 | Experimental | 3h IV POL7080 infusion |
|
| Normal Renal function | Experimental | 3h IV POL7080 infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POL7080 | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure the plasma concentrations of POL7080 | at baseline, 0.5, 1,1.5 and 3 hours after start of infusion, at 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and 72 hours after end of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of adverse events reported by the patients or observed by the investigator will be recorded. Onset, end date, severity, causal relationship, outcome and measures taken will be summarized. Discontinuations and serious adverse events will be listed and narrative summaries will be provided. | Daily assessment up to 7 days from informed consent |
Not provided
Inclusion Criteria:
Subjects who signed informed consent.
Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of age of non-childbearing potential
Weight within a BMI range of 19.0-35.0 kg/m2.
CLCr according to Cockcroft Gault equation of:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Atef Halabi, MD | CRS Clinical Research Services Kiel GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | 24105 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30012756 | Derived | Dale GE, Halabi A, Petersen-Sylla M, Wach A, Zwingelstein C. Pharmacokinetics, Tolerability, and Safety of Murepavadin, a Novel Antipseudomonal Antibiotic, in Subjects with Mild, Moderate, or Severe Renal Function Impairment. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00490-18. doi: 10.1128/AAC.00490-18. Print 2018 Sep. |
Not provided
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 |
|---|---|
| C000629572 | murepavadin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Laboratory abnormalities | The number and severity of blood chemistry and hematology findings will be summarized descriptively and compared to baseline. | Screening, Day -1, Day 2, Day 3, and Day 7 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |