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Bacterial InfectionsPhase 1NCT03939429

Phase 1 Study of Oral QPX2015 in Healthy Adult Subjects

A Phase 1 study testing QPX2015 in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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?
QPX2015
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteAustralia
Study dates
20 May 2019to 6 Oct 2019
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-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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • CMAX

    Adelaide, South Australia

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Oral QPX2015 in Healthy Adult Subjects

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.

Read the detailed description

The worldwide spread of resistance to antibiotics among gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of both hospital acquired and community acquired infections. In particular, the increase in Enterobacteriaceae expressing extended spectrum beta-lactamases (ESBLs) and carbapenemases that are resistant to all oral beta-lactams and fluoroquinolones in the community have resulted in many patients requiring admission just for IV antibiotics to treat their infections.

Qpex Biopharma is developing a fixed combination antibiotic of QPX2015 (beta-lactam antibiotic) plus a new beta-lactamase inhibitor.

Being tested
QPX2015, Placebo oral capsule
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.

  • QPX2015Drug

    Also called oral dose

    antibiotic

  • Placebo oral capsuleDrug

    Also called oral dose

    Placebo comparator

Study groups in NCT03939429
Study groupRoleWhat they receive
QPX2015ExperimentalQPX2015, antibiotic
Receives: Drug: QPX2015
PlaceboPlacebo comparatorMatched placebo
Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Study Day 1 to 13

  2. 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: Study Day 1 to 13

  3. 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.

    Measured: Study Day 1 to 13

  4. Time concentration data measurements by subject and by cohort (Tmax)

    Comparison will be performed between the cohorts for Tmax.

    Measured: Study Day 1 to 13

  5. 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.

    Measured: Study Day 1 to 13

  6. Urine PK amount excreted by subject and by cohort

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

    Measured: Study Day 1 to 13

  7. 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

    Measured: Study Day 1 to 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start20 May 2019
  3. Primary completion6 Oct 2019
  4. Study completion6 Oct 2019

Resources

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, placebo controlled ascending single- and multiple-dose
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03939429
Sponsor's protocol ID
Qpex-100
Status last verified
May 2019
First submitted
1 May 2019
Last updated
10 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38059635

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing QPX2015 in people with Bacterial Infections, run by Qpex Biopharma, Inc. at 1 site in Australia.

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 6 inclusion and 15 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 Australia. 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. Some participants in this study may receive a placebo. 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?

Incidence of Treatment -Emergent Adverse events by subject and by cohort (time frame: Study Day 1 to 13). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03939429, which also lists 1 linked publication.

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.

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