Phase 1 Study of Oral QPX2015 in Healthy Adult Subjects

NCT03939429 | Completed Phase 1 DMC

• 1 other identifier: Qpex-100
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

QPX2015 (beta-lactam antibiotic) is being studied at higher than approved doses to combine with a new beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.

Conditions

Bacterial Infections

Keywords

beta-lactam antibiotic

Outcome Measures

Primary Outcomes (7)

• Incidence of Treatment -Emergent Adverse events by subject and by cohort

  Number of patients with Treatment-Emergent AEs by treatment arm, severity and relationship to treatment

  Study Day 1 to 13

• 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

  Study Day 1 to 13

• Peak plasma Concentration measurements by subject and by cohort (Cmax)

  Comparison will be performed between the cohorts for Cmax. Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.

  Study Day 1 to 13

• Time concentration data measurements by subject and by cohort (Tmax)

  Comparison will be performed between the cohorts for Tmax.

  Study Day 1 to 13

• Area under the plasma concentration versus time curve (AUC) between cohorts

  Comparison will be performed between the cohorts for AUC. Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.

  Study Day 1 to 13

• Urine PK amount excreted by subject and by cohort

  Urine PK parameters such as amount excreted will be calculated from urinary excretion data

  Study Day 1 to 13

• Urine PK % dose excreted by subject and by cohort

  Urine PK parameters such as amount of % dose excreted will be calculated from urinary excretion data

  Study Day 1 to 13

Study Arms (2)

QPX2015

EXPERIMENTAL

QPX2015, antibiotic

Drug: QPX2015

Placebo

PLACEBO COMPARATOR

Matched placebo

Drug: Placebo oral capsule

Interventions

QPX2015 DRUG

antibiotic

Also known as: oral dose

QPX2015

Placebo oral capsule DRUG

Placebo comparator

Also known as: oral dose

Placebo

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-child bearing potential, 18 to 55 years of age (inclusive).
• Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
• 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.
• If male, agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from study check-in through completion of the end-of-study. Subjects must agree to use two approved methods of contraception for 30 days following the last administration of the study drug, and to not donate sperm during this same period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary.
• Females of non-childbearing potential with serum FSH levels ≥ 40 mIU/mL are either postmenopausal (defined as 12 months spontaneous amenorrhea) or have undergone sterilization procedures at least 6 months prior to dosing.

You may not qualify if:

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• Positive urine drug/alcohol testing at screening or check-in (Day -1).
• Positive testing for HIV, hepatitis B or C
• History or presence of alcoholism or drug abuse within last 2 years
• Use of more than 5 packs/week of tobacco/nicotine-containing product within last 6 months prior dosing.
• Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to dosing.
• Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to dosing.
• Use of antacids, H2 receptor blockers or proton pump inhibitors 3 days prior to dosing.
• History of any hypersensitivity or allergic reaction to cephalosporins, penicillins, carbapenems, or monobactams).
• Participation in another investigational clinical trial within 30 days prior to Dosing or within 5 half-lives of the previous investigational drug, whichever is longer.
• Females who are pregnant or lactating.
• QTcF interval \>450 msec, or history of prolonged QT syndrome at screening or check-in
• Calculated creatinine clearance less than 80 mL/min (Cockcroft-Gault method) at screening or check-in.
• Subjects who have any clinically significant abnormalities on laboratory values: White blood cell count \< 3,000/mm3, hemoglobin \< 11g/dL or Absolute neutrophil count \< 1,200/mm3 or platelet count \< 120,000/mm3.
• Liver function abnormalities defined by an elevation in bilirubin, AST or ALT 1.5 x ULN of the normal range for subjects based on age and sex.

Sponsors & Collaborators

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

Study Sites (1)

CMAX

Adelaide, South Australia, Australia

Location

Related Publications (1)

• Hernandez-Mitre MP, Wallis SC, Morgan EE, Dudley MN, Loutit JS, Griffith DC, Roberts JA. A phase I, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of the pharmacokinetics, safety, and tolerability of oral ceftibuten in healthy adult subjects. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0109923. doi: 10.1128/aac.01099-23. Epub 2023 Dec 7.

  PMID: 38059635 DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Jeffery S Loutit, MBChB

  Qpex Biopharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind, placebo controlled ascending single- and multiple-dose
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, placebo controlled ascending single- and multiple-dose

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 6, 2019
• Study Start: May 20, 2019
• Primary Completion: October 6, 2019
• Study Completion: October 6, 2019
• Last Updated: October 10, 2022

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)