Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects

All Participants (Cohorts 1-5)

Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements and study-related procedures

Willing to be confined to the Clinical Research Unit for the entire duration required by the protocol, able to comply with all study-related requirements and able to adhere to study restrictions and visit schedules

Male or female, between 18 and 75 years of age (inclusive) at the time of Screening

Body mass index (BMI) between 18 and 40 kilograms per meters squared (kg/m\^2) (inclusive) at the time of Screening

Female participants must:

* be non-pregnant and non-lactating;

* be either postmenopausal (defined as amenorrhea for ≥12 months with a confirmed follicle stimulating hormone \[FSH\] ≥40 milli International Units per milliliter \[mIU/mL\]), surgically sterile (defined as having undergone hysterectomy and/or bilateral oophorectomy), practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable), or agree to use an appropriate method of birth control consistently throughout the study and continue to use this method for 30 days (or 5 half-lives, whichever is longer) after study drug administration;

* Hormonal contraception and double barrier methods of non-hormonal contraception are permitted in this study. Acceptable forms of contraception include the following:

* oral, implantable, transdermal, injectable, or intravaginal hormonal contraception used consistently for at least 1 month prior to Screening;

* intrauterine device;

* female condom with spermicide (cream, spray, gel, suppository, contraceptive sponge, or polymer film);

* contraceptive sponge with condom;

* diaphragm with spermicide (with or without a condom);

* cervical cap with spermicide (with or without a condom);

* male sexual partner who agrees to use a male condom in addition to female participant's use of spermicide (cream, spray, gel, suppository, contraceptive sponge, or polymer film);

* male sexual partner who has been vasectomized for at least 3 months prior to Screening and who has obtained a follow-up negative sperm count;

* bilateral tubal ligation;

* Essure® procedure.

Male participants who are sexually active with a partner of child-bearing potential must either be sterile (vasectomy with history of a negative sperm count following the procedure); practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable); use a male condom with any sexual activity; or agree to use a birth control method considered to be appropriate by the Investigator (such as one of the methods identified above for female participants of childbearing potential) from the time of Screening until 90 days after study drug administration. Male participants must agree not to donate sperm for a period of 90 days after study drug administration.

Healthy Participants (Cohort 1)

Considered by the Investigator to be healthy, based on medical and surgical history, and a complete physical examination including vital signs (VS), a 12-lead electrocardiogram (ECG), and laboratory test results. A single repeat assessment is permitted for any VS, ECG, or laboratory parameter required for enrollment.

Estimated creatinine clearance ≥90 milliliters per minute (mL/min) (based on Cockcroft-Gault equation) determined at Screening

Matched demographically with a participant in Cohort 4 (severe RI) according to gender, BMI (±20%), and age (±10 years)

Has been a non-smoker (tobacco) for at least 30 days

Healthy participants must not be taking any prescribed or non-prescribed medications, including vitamins and other dietary or herbal supplements, unless permitted (e.g., hormonal contraception, low dose aspirin \[81 milligrams (mg)/day or less\]).

Participants with RI (Cohorts 2-4)

Participant has been diagnosed with RI in one of the three groups (e.g., mild, moderate, or severe) as defined by estimated glomerular filtration rate using the Modified Diet in Renal Disease equation at Screening

Considered by the Investigator to be clinically stable with respect to underlying RI, based on medical evaluation that includes medical and surgical history, as well as a complete physical examination including VS, ECG, and laboratory test results. A single repeat assessment is permitted for any VS, ECG, or laboratory parameter required for enrollment.

Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin within 1.5 × upper limit of normal (ULN) at Screening

Participants with renal impairment will be allowed to take their chronic medications unless excluded by the protocol. Excluded medications are restricted starting 7 days prior to study drug administration on Day 1 until the end of study visit. The occasional use of acetaminophen (≤2 grams per day) is permitted at the discretion of the Investigator.

Will smoke ≤10 cigarettes (and consume no more than the cumulative equivalent amount of nicotine) per day from Screening until the Follow-up visit

Participants with ESRD Requiring HD (Cohort 5)

In addition to the criteria specified above for all participants, participants with ESRD requiring HD must also meet the following criteria:

Diagnosed with ESRD and is on a stable HD regimen, defined as kt/V ≥1.2 within 3 months prior to Screening

Typically attends 3 HD treatments per week within the 3 months prior to Screening, as determined by the Investigator

Considered by the Investigator to be clinically stable with respect to underlying ESRD, based on medical evaluation that includes medical and surgical history, and a complete physical examination including VS, ECG, and laboratory test results. A single repeat assessment is permitted for any laboratory, ECG, or VS parameter required for enrollment.

AST, ALT, and total bilirubin within 1.5 × ULN at Screening

Participants with ESRD will be allowed to take their chronic medications unless excluded by the protocol. Excluded medications are restricted starting 7 days prior to study drug administration on Day 1 until the end of study visit. The occasional use of acetaminophen (≤2 grams per day) is permitted at the discretion of the Investigator.

Will smoke ≤10 cigarettes (and consume no more than the cumulative equivalent amount of nicotine) per day from Screening until the Follow-up visit.

What this study is about