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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03939429




Registration number
NCT03939429
Ethics application status
Date submitted
1/05/2019
Date registered
6/05/2019

Titles & IDs
Public title
Phase 1 Study of Oral QPX2015 in Healthy Adult Subjects
Scientific 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
Secondary ID [1] 0 0
Qpex-100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Infections 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QPX2015
Treatment: Drugs - Placebo oral capsule

Experimental: QPX2015 - QPX2015, antibiotic

Placebo comparator: Placebo - Matched placebo


Treatment: Drugs: QPX2015
antibiotic

Treatment: Drugs: Placebo oral capsule
Placebo comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment -Emergent Adverse events by subject and by cohort
Timepoint [1] 0 0
Study Day 1 to 13
Primary outcome [2] 0 0
Number of patients with changes from baseline in safety parameters
Timepoint [2] 0 0
Study Day 1 to 13
Primary outcome [3] 0 0
Peak plasma Concentration measurements by subject and by cohort (Cmax)
Timepoint [3] 0 0
Study Day 1 to 13
Primary outcome [4] 0 0
Time concentration data measurements by subject and by cohort (Tmax)
Timepoint [4] 0 0
Study Day 1 to 13
Primary outcome [5] 0 0
Area under the plasma concentration versus time curve (AUC) between cohorts
Timepoint [5] 0 0
Study Day 1 to 13
Primary outcome [6] 0 0
Urine PK amount excreted by subject and by cohort
Timepoint [6] 0 0
Study Day 1 to 13
Primary outcome [7] 0 0
Urine PK % dose excreted by subject and by cohort
Timepoint [7] 0 0
Study Day 1 to 13

Eligibility
Key inclusion criteria
1. Healthy adult males and/or females of non-child bearing potential, 18 to 55 years of age (inclusive).
2. Body mass index (BMI) = 18.5 and = 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
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. 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.
6. 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
2. Positive urine drug/alcohol testing at screening or check-in (Day -1).
3. Positive testing for HIV, hepatitis B or C
4. History or presence of alcoholism or drug abuse within last 2 years
5. Use of more than 5 packs/week of tobacco/nicotine-containing product within last 6 months prior dosing.
6. Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to dosing.
7. Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to dosing.
8. Use of antacids, H2 receptor blockers or proton pump inhibitors 3 days prior to dosing.
9. History of any hypersensitivity or allergic reaction to cephalosporins, penicillins, carbapenems, or monobactams).
10. 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.
11. Females who are pregnant or lactating.
12. QTcF interval >450 msec, or history of prolonged QT syndrome at screening or check-in
13. Calculated creatinine clearance less than 80 mL/min (Cockcroft-Gault method) at screening or check-in.
14. 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.
15. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/10/2019
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Qpex Biopharma, Inc.
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Biomedical Advanced Research and Development Authority
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffery S Loutit, MBChB
Address 0 0
Qpex Biopharma, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03939429