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| Name | Class |
|---|---|
| Clinical Research Center Kiel GmbH | OTHER |
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This is an open-label, non-randomized, single-center, single i.v. dose Phase 1 trial to evaluate the pharmacokinetics and safety of a combination of ANT3310 and meropenem in participants with different degrees of renal function impairment, including participants with End-Stage Renal Disease (ESRD), compared with matching control participants with normal renal function.
The participants will receive 1 single dose of the combination of ANT3310 and meropenem (2 times a single dose in participants with ESRD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANT3310 and Meropenem | Experimental | Participants with mild, moderate, or severe renal function impairment (Panel A, B, and D) and participants with normal renal function (Panel C and F) will receive 1 single dose of a combination of ANT3310 and meropenem. Participants with End Stage Renal Disease (Panel E) will receive 2 times a single dose of a combination of ANT3310 and meropenem: one single dose during dialysis-free interval ("off- dialysis") and one single dose on the day of dialysis ("on-dialysis"). The same dose will be given in both periods with a washout interval of at least 7 days between administrations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANT3310 | Drug | ANT3310 will be administered as a single intravenous infusion over 3 hours at a constant rate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentrations (Cmax) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma. | From pre-dose to Day 3 |
| Area under the curve from 0 to infinity (AUC0-inf) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma. | From pre-dose to Day 3 |
| Time from dosing to maximum observed concentration (tmax) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma. | From pre-dose to Day 3 |
| Apparent terminal elimination half-life (t1/2λz) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma. | From pre-dose to Day 3 |
| Area under the curve from time 0 to time of last measurable concentration (AUC0-last) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma. | From pre-dose to Day 3 |
| Area under the curve from time 0 to 48h (AUC0-48h) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma. | From pre-dose to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of treatment-emergent adverse event (TEAE) to evaluate the safety and tolerability of ANT3310 and meropenem after a single i.v. infusion of a combination of ANT3310 and meropenem. | Percentage of participants experiencing ≥ one treatment-emergent adverse event (TEAE) by seriousness, intensity, and relatedness from baseline to end of study (EoS) or early withdrawal. | 0 hours to Day 9 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Zwingelstein, PharmD | Antabio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | D-24105 | Germany |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Meropenem | Drug | meropenem will be administered as a single intravenous infusion over 3 hours at a constant rate. |
|
| Percentage of AUC0-inf obtained by extrapolation (AUCext) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma. | From pre-dose to Day 3 |
| Total body clearance (CL) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma. | From pre-dose to Day 3 |
| Non-renal clearance (CLNonR) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma and urine. | From pre-dose to Day 3 |
| Apparent volume of distribution during the terminal phase after administration (Vz) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma. | From pre-dose to Day 3 |
| Mean residence time (MRT) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in plasma. | From pre-dose to Day 3 |
| Amount of ANT3310 and Meropenem that is eliminated in urine from 0 to infinity (Ae0-inf) after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in urine. | From pre-dose to Day 3 |
| Renal clearance (CLR) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in urine. | From pre-dose to Day 3 |
| Fraction of dose recovered in urine (fe) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in urine. | From pre-dose to Day 3 |
| Amount of ANT3310 and Meropenem that is eliminated in urine from 0 to 48h (Ae0-48h) after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in urine. | From pre-dose to Day 3 |
| Fraction of dose recovered in urine from 0 to 48 hours (fe0-48h) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in urine. | From pre-dose to Day 3 |
| Renal clearance from 0 to 48 hours (CLR[0-48h]) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem | Pharmacokinetic parameter of ANT3310 and Meropenem in urine. | From pre-dose to Day 3 |
| Dialysis clearance (CLD) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem in dialysed subjects | Pharmacokinetic parameter of ANT3310 and Meropenem in dialysate and plasma. | during dialysis |
| Number of participants who discontinue due to a TEAE. | Percentage of participants who discontinue due to a TEAE. | 0 hours to Day 9 |
| Number of participants who meet the clinically significant abnormal criteria for safety laboratory tests at least once after start of dosing. | Percentage of participants who meet the clinically significant abnormal criteria for safety laboratory tests at least once after start of dosing. | 0 hours to Day 9 |
| Number of participants meeting the clinically significant abnormal criteria for vital signs measurements at least once after start of dosing. | Percentage of participants meeting the clinically significant abnormal criteria for vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) measurements at least once after start of dosing. | 0 hours to Day 9 |
| Number of participants who meet the clinically significant abnormal criteria for ECG (Electrocardiogram) parameters. | Percentage of participants who meet the clinically significant abnormal criteria for ECG parameters. | Day-1 to Day 9 |
| Number of infusion site reactions to assess local venous tolerability | From pre-dose on Day 1 to Day 3 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |