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

Launched by QPEX BIOPHARMA, INC. · Sep 28, 2021

Keywords

ClinConnect Summary

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, ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy adult males and/or females of non-childbearing potential, 18 to 55 years of age (inclusive) at the time of screening.
• • 2. 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.
• • 3. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms \[ECGs\], physical examination) as assessed by the PI.
• • 4. Voluntarily consent to participate in the study.
• • 5. 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:
• • 1. 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.
• • 2. Barrier method (diaphragm) for at least 14 days prior to Day 1 through 30 days following dosing of the study drug.
• • 3. Stable hormonal contraceptive for at least 3 months prior to Day 1 through 30 days following dosing of the study drug.
• • 4. Surgical sterilization (vasectomy) at least 6 months prior to Day 1.
• 6. 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):
• • 1. Bilateral tubal ligation;
• • 2. Hysterectomy;
• • 3. Hysterectomy with unilateral or bilateral oophorectomy;
• • 4. Bilateral oophorectomy.
• Exclusion Criteria:
• • 1. History or presence of significant (based on the PI assessment) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• • 2. Positive pregnancy test at screening or check-in (Day 1) for women.
• • 3. 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.
• • 4. Positive pregnancy test at screening or check-in (Day 1) for women.
• • 5. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
• • 6. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
• • 7. 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.
• • 8. 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).
• • 9. Use of any prescription medication (with the exception of hormone replacement therapy for females) within 14 days prior to Day 1.
• • 10. 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.
• • 11. Use of antacids, H2 receptor blockers or proton pump inhibitors within 3 days prior to Day 1.
• • 12. Documented hypersensitivity reaction or anaphylaxis to any medication, including beta-lactam antibiotics.
• • 13. Blood donation or significant blood loss (i.e., \> 500 mL) within 56 days prior to Day 1.
• • 14. Plasma donation within 7 days prior to Day 1.
• • 15. 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.
• • 16. 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.
• • 17. Any significant acute illness (based on the PI assessment) within 30 days prior to Day 1.
• • 18. QTcF interval \>450 msec for males and \>470 msec for females or history of prolonged QT syndrome at screening or check-in (Day -1).
• • 19. Calculated creatinine clearance less than 80 mL/min (Cockcroft- Gault method) at screening or check-in (Day -1).
• 20. Subjects who have any clinically significant laboratory value abnormalities at screening or check-in (Day -1), in particular:
• • 1. White blood cell count \< 3,000/mm3, hemoglobin \< 11g/dL.
• • 2. Absolute neutrophil count \< 1,200/mm3 or platelet count \< 120,000/mm3.
• • 21. 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).
• • 22. Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study.
• • 23. Participation in a previous QPX7728 or QPX7831 study.
• • 24. Participation of research site staff, their close family, or significant others.