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

NCT05072444 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: Qpex-201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Bacterial Infections

Keywords

beta-lactam antibiotic

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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

  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

  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

  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

  up to 9 days

Study Arms (2)

QPX7728

EXPERIMENTAL

Drug: QPX7728 beta lactamase inhibitor Other names: IV

Drug: QPX7728; Drug: QPX2014

QPX2014

EXPERIMENTAL

Drug: QPX2014 antibiotic Other names: IV

Drug: QPX2014

Interventions

QPX7728 DRUG

beta lactamase inhibitor

Also known as: IV

QPX7728

QPX2014 DRUG

antibiotic

Also known as: IV

QPX2014; QPX7728

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Qpex Biopharma, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Altasciences

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

QPX7728

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Jeff S Loutit, MBChB

  Qpex Biopharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Blind, Single-Dose
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blind, Single-Dose, Drug-Drug Interaction Study

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 11, 2021
• Study Start: November 15, 2021
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: October 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)