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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-JW180095-B | Other Grant/Funding Number | United States Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPR206 | Experimental | SPR206 100mg single-dose IV infused over 1 hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPR206 | Drug | SPR206 100 mg single-dose IV infused over 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to the maximum plasma concentration (Tmax) | 36 hours after start of study drug IV infusion | |
| Maximum plasma concentration (Cmax) | 36 hours after start of study drug IV infusion | |
| Area under the concentration-time curve from time 0 to last measurable timepoint (AUC0-t) | 36 hours after start of study drug IV infusion | |
| Area under the concentration-time curve from time 0 to infinity (AUC0-∞) | 36 hours after start of study drug IV infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to 8 hours (AUC0-8) | 8 hours after start of study drug IV infusion | |
| Terminal Elimination Rate Constant (kel) | 36 hours after start of study drug IV infusion |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Melnick, MD | Spero Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Facility | Auckland | 1010 | New Zealand | |||
| Medical Facility |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Terminal half-life (t1/2) | 36 hours after start of study drug IV infusion |
| Total body clearance (CL) | 36 hours after start of study drug IV infusion |
| Renal clearance (CLR) | 36 hours after start of study drug IV infusion |
| Steady-state volume of distribution (Vss) | 36 hours after start of study drug IV infusion |
| Amount of drug excreted in urine by interval (Aet) for Cohorts 1-4 | 36 hours after start of study drug IV infusion |
| Cumulative amount of drug excreted in urine at the end of each interval (Aeu) for Cohorts 1-4 | 36 hours after start of study drug IV infusion |
| Fraction of drug excreted in the urine expressed as a percentage (Ae%) for Cohorts 1-4 | 36 hours after start of study drug IV infusion |
| Fraction of dose excreted in the urine over a collection interval (Fe) for Cohorts 1-4 | 36 hours after start of study drug IV infusion |
| Cumulative fraction of dose excreted in the urine over (Feu) for Cohorts 1-4 | 36 hours after start of study drug IV infusion |
| Extraction ratio (ER) for subjects on dialysis (Cohort 5) | Up to 1 day post dose - between start and end of hemodialysis |
| Estimated hemodialysis clearance (CLHD) for subjects on dialysis (Cohort 5) | Up to 1 day post dose - between start and end of hemodialysis |
| Amount of the dose removed by hemodialysis (XHD) for subjects on dialysis (Cohort 5) | Up to 1 day post dose - between start and end of hemodialysis |
| Incidence of Treatment-Emergent Adverse Events | To assess the incidents of treatment-emergent adverse events following SPR206 intravenous dose administration. AEs will be classified by System Organ Class (SOC) and Preferred Term (PT). Incidence, frequency, severity and duration will be presented. | 14 days post start of last study drug IV infusion |
| Incidence of abnormal vital sign assessments - blood pressure | To assess the incidents of abnormal systolic and diastolic blood pressure assessments following SPR206 intravenous dose administration. Values and changes from baseline at each scheduled time-point will be summarized using descriptive statistics (n, mean, SD, median, minimum, and maximum). Significant changes from baseline will be presented. | 14 days post study drug IV infusion |
| Incidence of abnormal vital sign assessments - body temperature | To assess the incidents of abnormal body temperature assessments following SPR206 intravenous dose administration. Values and changes from baseline at each scheduled time-point will be summarized using descriptive statistics (n, mean, SD, median, minimum, and maximum). Significant changes from baseline will be presented. | 14 days post study drug IV infusion |
| Incidence of abnormal physical exam assessments | To assess the incidents of abnormal body system assessments following SPR206 intravenous dose administration. Changes from baseline in physical examination findings will be classified as Normal, Abnormal NCS, and Abnormal CS. Frequency counts will be presented. | 14 days post study drug IV infusion |
| Incidence of abnormal ECG assessments - heart rate | To assess the incidents of abnormal heart rate assessment following SPR206 intravenous dose administration. Cardiac (12-Lead ECG) for heart rate will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented. | 14 days post study drug IV infusion |
| Incidence of abnormal ECG assessments - PR, RR, QRS, QT and QTcF interval | To assess the incidents of abnormal PR interval, RR interval, QRS interval, QT interval and QTcF interval assessments following SPR206 intravenous dose administration. Cardiac (12-Lead ECG) results will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented. | 14 days post study drug IV infusion |
| Incidence of abnormal safety laboratory assessments | To assess the incidents of abnormal hematology, serum chemistry, coagulation and urinalysis assessments following SPR206 intravenous dose administration. Values and changes from baseline at each scheduled time-point will be summarized using descriptive statistics (n, mean, SD, median, minimum, and maximum). Frequency counts of significant changes from baseline will be presented. | 14 days post study drug IV infusion |
| Christchurch |
| 8011 |
| New Zealand |
| D052801 | Male Urogenital Diseases |