Bacterial InfectionsPhase 1NCT05072444
Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects
A Phase 1 study testing QPX7728 and QPX2014 in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 1 site in United States.
Trial summary
QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous beta-lactamases, including class A extended spectrum betalactamases (ESBLs), class C cephalosporinases, and extended spectrum class D oxacillinases (OXA) that can hydrolyze cephalosporins and can be found in Enterobacteriaceae… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- QPX7728 and QPX2014
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 23 Nov 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and/or females of non-childbearing potential, 18 to 55 years of age (inclusive) at the time of screening.
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) at the time of screening.
- Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms [ECGs], physical examination) as assessed by the PI.
- Voluntarily consent to participate in the study.
- Male volunteers must agree to be sexually abstinent or agree to use a condom when engaging in any sexual activity from study check-in (on Day -1) through 30 days following the last administration of the study drug, and to not donate sperm during this same period of time. If engaging in sexual activity with a female partner of childbearing potential, an additional method of birth control must be used.
- Approved additional methods of birth control include:
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- Intrauterine device (IUD) in place for at least 3 months prior to Day 1 through 30 days following the final dosing of the study drug.
- Barrier method (diaphragm) for at least 14 days prior to Day 1 through 30 days following dosing of the study drug.
- Stable hormonal contraceptive for at least 3 months prior to Day 1 through 30 days following dosing of the study drug.
- Surgical sterilization (vasectomy) at least 6 months prior to Day 1.
- Females of non-childbearing potential must be either postmenopausal (defined as 12 months spontaneous amenorrhea) with a serum FSH ≥ 40 mIU/mL or have undergone one of the following sterilization procedures at least 6 months prior to Day 1 (and is documented):
- Bilateral tubal ligation;
- Hysterectomy;
- Hysterectomy with unilateral or bilateral oophorectomy;
- Bilateral oophorectomy.
Who cannot join
- History or presence of significant (based on the PI assessment) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive pregnancy test at screening or check-in (Day 1) for women.
- Positive urine drug/alcohol testing at screening or check-in (Day -1). A repeat test may be performed at the Investigator's discretion in circumstances where a positive result is suspected to be caused by consumption of non-illicit substances.
- Positive pregnancy test at screening or check-in (Day 1) for women.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
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- Use of more than an average of 5 packs/week of tobacco/nicotine-containing product within 6 months prior to Day 1. Subjects must agree to refrain from smoking within 48 hours prior to confinement and for the duration of the study.
- Excessive intake of alcohol, defined as an average daily intake of greater than 2 standard drinks for women and 4 standard drinks for men, (1 bottle of beer (375mL) is equivalent to approximately 1.4 standard drinks, 1 glass of spirits (30mL) is equivalent to approximately 1 standard drink and 1 glass (150mL) of wine is equivalent to approximately 1.5 standard drinks).
- Use of any prescription medication (with the exception of hormone replacement therapy for females) within 14 days prior to Day 1.
- Use of any over-the-counter (OTC) medication, including herbal products, probiotics and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
- Use of antacids, H2 receptor blockers or proton pump inhibitors within 3 days prior to Day 1.
- Documented hypersensitivity reaction or anaphylaxis to any medication, including beta-lactam antibiotics.
- Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1.
- Plasma donation within 7 days prior to Day 1.
- Participation in another investigational clinical trial within 30 days prior to Day 1 or within 5 half-lives of the previous investigational drug, whichever is longer.
- Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant. Minor surgeries allowed include laser vision, minor dental and tooth extraction, mole or basal cell skin removal, endoscopy, and biopsy.
- Any significant acute illness (based on the PI assessment) within 30 days prior to Day 1.
- QTcF interval >450 msec for males and >470 msec for females or history of prolonged QT syndrome at screening or check-in (Day -1).
- Calculated creatinine clearance less than 80 mL/min (Cockcroft- Gault method) at screening or check-in (Day -1).
- Subjects who have any clinically significant laboratory value abnormalities at screening or check-in (Day -1), in particular:
- White blood cell count < 3,000/mm3, hemoglobin < 11g/dL.
- Absolute neutrophil count < 1,200/mm3 or platelet count < 120,000/mm3.
- Liver function abnormalities at screening or check-in (Day -1) (defined by an elevation in bilirubin, AST or ALT > ULN for subjects based on age and sex).
- Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study.
- Participation in a previous QPX7728 or QPX7831 study.
- Participation of research site staff, their close family, or significant others.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Single-Dose, Drug-Drug Interaction Study to Determine the Impact of Co-administration of QPX7728 on the Pharmacokinetics of QPX2014 in Healthy Adult Subjects
QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous beta-lactamases, including class A extended spectrum betalactamases (ESBLs), class C cephalosporinases, and extended spectrum class D oxacillinases (OXA) that can hydrolyze cephalosporins and can be found in Enterobacteriaceae and Pseudomonas aeruginosa (P. aeruginosa). QPX7728 is also a potent inhibitor of carbapenemases from all molecular classes, such as class A Klebsiella pheumoniae carbapenemase (KPC), class B New-Dehli Metalo-beta-lactamase (NDM) and Verona integron-encoded metallo-betalactamase (VIM), and class D OXA-48 that are found in carbapenem resistant Enterobacteriaceae, and also class D carbapenemases such as OXA-23 that are found in carbapenem resistant Acinetobacter baumannii.
Read the detailed description
The Centers for Disease Control (CDC) has listed carbapenem-resistant Enterobacteriaceae and Acinetobacter as urgent threats and multidrug resistant Pseudomonas, and extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae as serious threats [CDC, 2019]. Consistent with the global nature of these resistant bacteria, the World Health Organization (WHO) has designated carbapenem-resistant, ESBL-producing Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii, and carbapenem-resistant Pseudomonas aeruginosa as pathogens for which new agents are critically needed [WHO, 2017]. Qpex Biopharma is developing a fixed combination antibiotic of QPX2014 plus an ultra-broad spectrum beta-lactamase inhibitor, QPX7728.
- Conditions
- Bacterial Infections
- Being tested
- QPX7728, QPX2014
- Keywords
- beta-lactam antibiotic
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QPX7728Drug
Also called IV
beta lactamase inhibitor
QPX2014Drug
Also called IV
antibiotic
| Study group | Role | What they receive |
|---|---|---|
| QPX7728 | Experimental | Drug: QPX7728 beta lactamase inhibitor Other names: IV Receives: Drug: QPX7728; Drug: QPX2014 |
| QPX2014 | Experimental | Drug: QPX2014 antibiotic Other names: IV Receives: Drug: QPX2014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) between dosing groups
Comparison will be performed between the dosing groups for AUC. Mean graphical presentation of the data will be reported.
Statistical analysis of exposure parameters will be performed.
Measured: up to 9 days
Peak plasma Concentration measurements by subject and by dosing group
Comparison will be performed between the dosing groups. Mean graphical presentation of the data will be reported.
Statistical analysis of exposure parameters will be performed.
Measured: up to 9 days
Urine Pharmacokinetic (PK) amount excreted by subject and by dosing group
Urine PK parameters such as amount excreted will be calculated from urinary excretion data
Measured: up to 9 days
Urine PK % dose excreted by subject and by dosing group
Urine PK parameters such as amount of % dose excreted will be calculated from urinary excretion data
Measured: up to 9 days
Incidence of Treatment -Emergent Adverse events (AEs) by subject and by dosing group
Number of patients with Treatment-Emergent AEs by treatment arm, severity and relationship to treatment
Measured: up to 9 days
Number of patients with changes from baseline in safety parameters
Number of patients with changes in safety parameters before and after dosing by subject and treatment arm
Measured: up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start15 Nov 2021
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blind, Single-Dose, Drug-Drug Interaction Study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qpex Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Jeff S Loutit, MBChB, Study director, Qpex Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072444
- Sponsor's protocol ID
- Qpex-201
- Status last verified
- Feb 2022
- First submitted
- 28 Sep 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Single-Dose, Drug-Drug Interaction Study to Determine the Impact of Co-administration of QPX7728 on the Pharmacokinetics of QPX2014 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05072444
- Acronym / sponsor ID
- Qpex-201
- Conditions
- Bacterial Infections
- Keywords
- beta-lactam antibiotic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Qpex Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 11 Oct 2021 (actual)
- 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.
QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous beta-lactamases, including class A extended spectrum betalactamases (ESBLs), class C cephalosporinases, and extended spectrum class D oxacillinases (OXA) that can hydrolyze cephalosporins and can be found in Enterobacteriaceae and Pseudomonas aeruginosa (P. aeruginosa). QPX7728 is also a potent inhibitor of carbapenemases from all molecular classes, such as class A Klebsiella pheumoniae carbapenemase (KPC), class B New-Dehli Metalo-beta-lactamase (NDM) and Verona integron-encoded metallo-betalactamase (VIM), and class D OXA-48 that are found in carbapenem resistant Enterobacteriaceae, and also class D carbapenemases such as OXA-23 that are found in carbapenem resistant Acinetobacter baumannii.
Detailed description
The Centers for Disease Control (CDC) has listed carbapenem-resistant Enterobacteriaceae and Acinetobacter as urgent threats and multidrug resistant Pseudomonas, and extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae as serious threats [CDC, 2019]. Consistent with the global nature of these resistant bacteria, the World Health Organization (WHO) has designated carbapenem-resistant, ESBL-producing Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii, and carbapenem-resistant Pseudomonas aeruginosa as pathogens for which new agents are critically needed [WHO, 2017]. Qpex Biopharma is developing a fixed combination antibiotic of QPX2014 plus an ultra-broad spectrum beta-lactamase inhibitor, QPX7728.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-Blind, Single-Dose, Drug-Drug Interaction Study
| Arm | Type | Receives |
|---|---|---|
| QPX7728 | Experimental | Drug: QPX7728, Drug: QPX2014Drug: QPX7728 beta lactamase inhibitor Other names: IV |
| QPX2014 | Experimental | Drug: QPX2014Drug: QPX2014 antibiotic Other names: IV |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy adult males and/or females of non-childbearing potential, 18 to 55 years of age (inclusive) at the time of screening.
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) at the time of screening.
- Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms [ECGs], physical examination) as assessed by the PI.
- Voluntarily consent to participate in the study.
- Male volunteers must agree to be sexually abstinent or agree to use a condom when engaging in any sexual activity from study check-in (on Day -1) through 30 days following the last administration of the study drug, and to not donate sperm during this same period of time. If engaging in sexual activity with a female partner of childbearing potential, an additional method of birth control must be used.
Key exclusion criteria (26 listed)
- History or presence of significant (based on the PI assessment) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive pregnancy test at screening or check-in (Day 1) for women.
- Positive urine drug/alcohol testing at screening or check-in (Day -1). A repeat test may be performed at the Investigator's discretion in circumstances where a positive result is suspected to be caused by consumption of non-illicit substances.
- Positive pregnancy test at screening or check-in (Day 1) for women.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
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 |
|---|---|---|
| QPX7728Also: IVbeta lactamase inhibitor | Drug | QPX7728 |
| QPX2014Also: IVantibiotic | Drug | QPX2014, QPX7728 |
Primary outcome
Area under the plasma concentration versus time curve (AUC) between dosing groups
Time frame: up to 9 days
Comparison will be performed between the dosing groups for AUC. Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.
Peak plasma Concentration measurements by subject and by dosing group
Time frame: up to 9 days
Comparison will be performed between the dosing groups. Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.
Urine Pharmacokinetic (PK) amount excreted by subject and by dosing group
Time frame: up to 9 days
Urine PK parameters such as amount excreted will be calculated from urinary excretion data
Urine PK % dose excreted by subject and by dosing group
Time frame: up to 9 days
Urine PK parameters such as amount of % dose excreted will be calculated from urinary excretion data
Incidence of Treatment -Emergent Adverse events (AEs) by subject and by dosing group
Time frame: up to 9 days
Number of patients with Treatment-Emergent AEs by treatment arm, severity and relationship to treatment
Number of patients with changes from baseline in safety parameters
Time frame: up to 9 days
Number of patients with changes in safety parameters before and after dosing by subject and treatment arm
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 10 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Jeff S Loutit, MBChB study director
Qpex Biopharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QPX7728 and QPX2014 in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 1 site in United States.
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 15 inclusion and 26 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 10 Oct 2022. 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. 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?
Area under the plasma concentration versus time curve (AUC) between dosing groups (time frame: up to 9 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2022.