The purpose of the study is look at the possible side effects of two different doses of
CXA-101/tazobactam, a low dose and a high dose, on participant's heart.
Some drugs can have effects on the cardiovascular system (hearts and blood vessels)
including the QT interval. The QT interval is the time between the contraction and
relaxation of the chambers of the heart, called ventricles, which collect and pump blood.
The use of some drugs can lead to serious issues such as QT interval prolongation (lengthen)
and potentially serious arrhythmias (abnormal heart beat), and sudden death. Therefore, it
is important to study effect of medications on the heart.
The drug, Moxifloxacin, will be introduced as a control to be able to compare the effect, if
any, that CXA 101/tazobactam might have on participant's heart.Moxifloxacin is an approved
antibiotic commonly used to treat common bacterial infections. Moxifloxacin is known to
slightly increase the electrical conduction of participant's heart.
- Healthy adult male and/or female, 18-45 years of age who can provide written Informed
- Body mass index (BMI) between 18-30, inclusive.
- Medically healthy with no clinically significant abnormal screening results
(laboratory profiles, medical histories, ECGs, physical exam.
- Voluntarily consent to participate in the study.
- Normal blood pressure (<140 mmHg systolic and <90 mmHg diastolic).
- Normal 12-lead ECG, as defined as:
Consistent sinus rhythm No clinically significant conduction disorders PR interval between
120 and 210 milliseconds (msec), inclusive Heart rate (HR) greater than or equal to 50
beats per minute (bpm) and less than or equal to 100 bpm QRS interval less than or equal
to 110 msec QT intervals that can be consistently analyzed (T wave amplitude 2 mm or
greater, lack of artifact [noise] and excessive baseline wandering, without any form of
bundle branch block).
- QTcF interval less than or equal to 430 msec for males and less than or equal to 450
msec for females.
- Calculated creatinine clearance >80 mL/min. at screening using the Cockcroft-Gault
- If female, subject must have a negative serum pregnancy test at screening and agrees
to either be sexually inactive (abstinent) for 14 days prior to screening and
throughout the study, or use one of the following acceptable birth control methods:
1. Intrauterine device (IUD) in place for at least 2 months prior to Day 1 and
through study completion; or,
2. Barrier method (condom or diaphragm) with spermicide for at least 14 days prior
to screening through study completion; or
3. Stable hormonal contraceptive (with the same medication, if possible) for at
least 3 months prior to Day 1 through one month after completion of study; or
4. Surgical sterilization (vasectomy) of partner at least 6 months prior to Day 1;
5. Naturally postmenopausal for a minimum of 2 consecutive years prior to Day 1; or
6. Surgically sterile (bilateral tubal ligation with surgery at least 6 months
prior to Day 1, hysterectomy, or bilateral oophorectomy with surgery at least 2
months prior to Day 1).
- If male, subject agrees to use a medically acceptable contraceptive defined as:
1. Abstain from sexual intercourse through study completion; or
2. Use a condom with spermicide through study completion; or
3. Have had a vasectomy at least 6 months prior to Day 1; or
4. Have a partner who is not of childbearing potential, through study completion.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or
- History of additional risk factors for Torsade de Pointes (e.g., hypokalemia, family
history of long QT Syndrome, family history of Short QT Syndrome, or family history
of unexplainable early sudden death).
- History of invasive cancer within the past 5 years (excluding non-melanoma skin
- History of sensitivity or allergy to the quinolone class of antibiotics,
cephalosporin class of antibiotics, or the beta-lactam class of antibiotics.
- History or presence of alcoholism or drug abuse within the past 2 years.
- History of hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV).
- History of clinically significant syncope.
- History of clinically significant psychiatric illness that would prevent the subject
from providing a valid Informed Consent Form (ICF).
- Use of tobacco products within the previous 6 months.
- Donation of blood within 45 days prior to Study Day 1.
- Plasma donation within 30 days prior to Study Day 1.
- Participation in a study of an investigational drug within 30 days prior to the
- Participation in another clinical trial within 30 days prior to the day of check-in
for this study.
- Female and pregnant or lactating.
- Has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or
any other clinically significant cardiovascular abnormality.
- Positive laboratory results for substances of abuse, cotinine, or alcohol.
- Taken any prescription medication (with the exception of hormonal birth control
medications or hormone replacement therapy) within 14 days (or 5 elimination
half-lives, whichever is longer) of admission to the unit (Day -2), or have taken any
over the counter (OTC) medications, including topical medications, vitamins, herbal
or dietary supplements/remedies (e.g., Saint John's Wort or Milk Thistle), within 14
days of admission, or planned concomitant medication while in the study (except for
acetaminophen or naproxen, if needed for headache or pain).
- In the opinion of the Investigator, subject would not be able to provide reliable
study data or be available for study follow-up.