HealthyPhase 1NCT02508753

Safety Study Designed to Study the Effects of Two Different Doses of CXA-101/Tazobactam, a Low Dose and a High Dose, on the QT/QTc Intervals in Healthy Subjects

A Phase 1 study testing CXA-101/tazobactam and Moxifloxacin in people with Healthy, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: CXA-101/tazobactam and Moxifloxacin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Jul 2010
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male and/or female, 18-45 years of age who can provide written Informed Consent.
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:

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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 formula.
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:
Intrauterine device (IUD) in place for at least 2 months prior to Day 1 and through study completion; or,
Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or
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
Surgical sterilization (vasectomy) of partner at least 6 months prior to Day 1; or
Naturally postmenopausal for a minimum of 2 consecutive years prior to Day 1; or
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:
Abstain from sexual intercourse through study completion; or
Use a condom with spermicide through study completion; or
Have had a vasectomy at least 6 months prior to Day 1; or
Have a partner who is not of childbearing potential, through study completion.

Who cannot join

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
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 cancers).
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).

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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 baseline ECG.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cetero Reserach
Fargo, North Dakota, 58104

Other trials in United States

About this study

Official title: A Double-Blind, Double-Dummy, Randomized, Moxifloxacin and Placebo Controlled, Four-Way Crossover Study of the Effects of a Single Intravenous Supra-Therapeutic Dose and Single Intravenous Therapeutic Dose of CXA-101/Tazobactam on the QT/QTC Intervals in Healthy Subjects

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.

Read the detailed description

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.

Conditions: Healthy
Being tested: CXA-101/tazobactam, Moxifloxacin, placebo
Keywords: QT/QTc Intervals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CXA-101/tazobactamDrug
1000/500 mg single IV dose administered over 60 minutes
CXA-101/tazobactamDrug
3000/1500 mg single IV dose administered over 60 minutes
MoxifloxacinDrug
400 mg tablet
placeboDrug
single IV dose of a saline solution administered over 60 minutes plus oral over-encapsulated moxifloxacin placebo tablet administered at the start of infusion.

Study groups in NCT02508753
Study group	Role	What they receive
CXA-101/tazobactam therapeutic dose	Experimental	Not described Receives: Drug: CXA-101/tazobactam
CXA-101/tazobactam supra-therapeutic dose	Experimental	Not described Receives: Drug: CXA-101/tazobactam
Moxifloxacin	Active comparator	Not described Receives: Drug: Moxifloxacin
Placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The change from the pre-dose baseline in the individual subject (subject-specific) correction, QTcI.
The primary endpoint is the baseline-adjusted change in the QTcI between time-matched placebo and study drug.
Measured: Baseline through Day 13
The change from the periodic specific pre-dose baseline of QT/QTcI
The primary endpoint is the change from the periodic specific pre-dose baseline of QT/QTcI corrected by QTcI across all dose groups
Measured: Baseline through Day 13

Secondary outcomes (3)

The change from pre-dose baseline in the QT/QTcI corrected by QTcB and QTcF interval.
Measured: Baseline through Day 13
Characterize concentration-response relationship for QT/QTcI
Measured: Baseline through Day 13
Provide safety information by the collection of adverse events
Collect AEs
Measured: Baseline through Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Jul 2010

First posted27 Jul 2015 (estimated)
Study startJun 2010
Primary completionJul 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02508753
Sponsor's protocol ID: 7625A-033
Other IDs: CXA-QT-10-02
Status last verified: Jan 2017
First submitted: 17 Jun 2010
Last updated: 26 Jan 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Double-Dummy, Randomized, Moxifloxacin and Placebo Controlled, Four-Way Crossover Study of the Effects of a Single Intravenous Supra-Therapeutic Dose and Single Intravenous Therapeutic Dose of CXA-101/Tazobactam on the QT/QTC Intervals in Healthy Subjects
ClinicalTrials.gov ID: NCT02508753
Acronym / sponsor ID: 7625A-033
Conditions: Healthy
Keywords: QT/QTc Intervals
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 27 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
CXA-101/tazobactam therapeutic dose	Experimental	Drug: CXA-101/tazobactam
CXA-101/tazobactam supra-therapeutic dose	Experimental	Drug: CXA-101/tazobactam
Moxifloxacin	Active comparator	Drug: Moxifloxacin
Placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (21 listed)

Healthy adult male and/or female, 18-45 years of age who can provide written Informed Consent.
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).

Key exclusion criteria (18 listed)

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
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 cancers).
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CXA-101/tazobactam1000/500 mg single IV dose administered over 60 minutes	Drug	CXA-101/tazobactam therapeutic dose
CXA-101/tazobactam3000/1500 mg single IV dose administered over 60 minutes	Drug	CXA-101/tazobactam supra-therapeutic dose
Moxifloxacin400 mg tablet	Drug	Moxifloxacin
placebosingle IV dose of a saline solution administered over 60 minutes plus oral over-encapsulated moxifloxacin placebo tablet administered at the start of infusion.	Drug	Placebo

Primary outcome

The change from the pre-dose baseline in the individual subject (subject-specific) correction, QTcI.
Time frame: Baseline through Day 13
The primary endpoint is the baseline-adjusted change in the QTcI between time-matched placebo and study drug.
The change from the periodic specific pre-dose baseline of QT/QTcI
Time frame: Baseline through Day 13
The primary endpoint is the change from the periodic specific pre-dose baseline of QT/QTcI corrected by QTcI across all dose groups

3 secondary outcomes

The change from pre-dose baseline in the QT/QTcI corrected by QTcB and QTcF interval.
Time frame: Baseline through Day 13
Characterize concentration-response relationship for QT/QTcI
Time frame: Baseline through Day 13
Provide safety information by the collection of adverse events
Time frame: Baseline through Day 21

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change from the pre-dose baseline in the individual subject (subject-specific) correction, QTcI. (time frame: Baseline through Day 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02508753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017; AzTrials last refreshed its copy on 30 Oct 2026.