Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ETX2514SUL · 1 trial · 1 indication
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analyses.
Venous blood will be collected for ETX2514SUL PK analyses.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
Venous blood will be collected for ETX2514SUL PK analyses.
Venous blood will be collected for ETX2514SUL PK analyses.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
AUC0-24 is defined as the area under the concentration versus time curve from time zero to 24 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-48 is defined as the area under the concentration versus time curve from time zero to 48 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-last is defined as the area under the concentration versus time curve from time zero to the time of the last quantifiable concentration after dosing. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-∞ is defined as the area under the concentration versus time curve from time zero extrapolated to infinity. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-24 is defined as the area under the concentration versus time curve from time zero to 24 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-48 is defined as the area under the concentration versus time curve from time zero to 48 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-60 is defined as the area under the concentration versus time curve from time zero to 60 hours. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-last is defined as the area under the concentration versus time curve from time zero to the time of the last quantifiable concentration after dosing. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-∞ is defined as the area under the concentration versus time curve from time zero extrapolated to infinity. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-24 is defined as the area under the concentration versus time curve from time zero to 24 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
AUC0-48 is defined as the area under the concentration versus time curve from time zero to 48 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
AUC0-60 is defined as the area under the concentration versus time curve from time zero to 60 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
AUC0-last is defined as the area under the concentration versus time curve from time zero to the time of the last quantifiable concentration after dosing. Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
AUC0-∞ is defined as the area under the concentration versus time curve from time zero extrapolated to infinity. Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, and 48 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 48 hours post infusion could fall on Day 3.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, 48, and 60 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, and 48 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 48 hours post infusion could fall on Day 3.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, 48, and 60 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, and 48 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 48 hours post infusion could fall on Day 3.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, 48, and 60 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, and 48 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 48 hours post infusion could fall on Day 3.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, 48, and 60 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion) and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 24 hours post infusion could fall on Day 2.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion), and 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 60 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion) and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 24 hours post infusion could fall on Day 2.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion), and 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 60 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion) and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 24 hours post infusion could fall on Day 2.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion), and 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 60 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
| Arm | Type | Description |
|---|---|---|
| Cohort 1, Normal Renal Function | EXPERIMENTAL | Healthy control participants matched to participants enrolled in Cohort 4 (creatinine clearance ≥90 milliliters per minute \[mL/min\] estimated by the Cockcroft-Gault equation) will receive ETX2514SUL as a single dose of up to 1000 milligrams (mg) ETX2514 and 1000 mg sulbactam given by concurrent 3-hour intravenous (IV) infusion. |
| Cohort 2, Mild Renal Impairment | EXPERIMENTAL | Participants with mild renal impairment (estimated glomerular filtration rate \[eGFR\] ≥60 to \<90 mL/min/1.73 meters squared \[m\^2\] calculated by the Modified Diet in Renal Disease \[MDRD\] equation) will receive ETX2514SUL as a single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hour IV infusion. |
| Cohort 3, Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate renal impairment (eGFR ≥30 to \<60 mL/min/1.73 m\^2 calculated by the MDRD equation) will receive ETX2514SUL as a single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hour IV infusion. |
| Cohort 4, Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment (eGFR \<30 mL/min/1.73 m\^2 calculated by the MDRD equation) and not on hemodialysis (HD) will receive ETX2514SUL as a single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hour IV infusion. |
| Cohort 5, ESRD on a Stable HD Regimen | EXPERIMENTAL | Participants with end-stage renal disease (ESRD) on a stable HD regimen (determined by medical history) will receive ETX2514SUL as a single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hour IV infusion. |
| Name | Type | Description |
|---|---|---|
| ETX2514SUL | DRUG | Single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hr IV infusion |
Inclusion Criteria: To qualify for enrollment in this study, each participant must meet the inclusion criteria for all participants, as well as all inclusion criteria specified for either healthy participants, participants with renal impairment (RI), or participants with end-stage renal disease (ES...
ETX2514SUL is an investigational small molecule being developed for the treatment of Acinetobacter baumannii infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
ETX2514SUL is a combination of ETX2514 and sulbactam. ETX2514 is a beta-lactamase inhibitor, and sulbactam is a beta-lactam antibiotic. The combination is designed to overcome beta-lactamase-mediated resistance in Acinetobacter baumannii.
ETX2514SUL is being developed by Innoviva, Inc. (NASDAQ: INVA). The company is conducting clinical trials to evaluate the safety and pharmacokinetics of the drug.
ETX2514SUL is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial has been completed.
ETX2514SUL has one completed Phase 1 trial, NCT03310463, which evaluated the pharmacokinetics, safety, and tolerability of intravenous ETX2514 and sulbactam in subjects with renal impairment and healthy controls. The trial enrolled 34 participants in the United States.
ETX2514SUL is a combination product containing ETX2514 and sulbactam. It is not the same as sulbactam alone, as it includes the beta-lactamase inhibitor ETX2514 to enhance activity against Acinetobacter baumannii.