Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects

Completed · Phase 1

Conditions studied: Bacterial Infections

In brief

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.

Key facts

Study ID

NCT05072444

Run by

Qpex Biopharma, Inc.

People needed

12

Starts

2021-11-15

Expected to finish

2021-11-23

Last updated by the study team

2022-10-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Altasciences — Cypress, California, United States

Full record on ClinicalTrials.gov

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