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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04578873




Registration number
NCT04578873
Ethics application status
Date submitted
29/09/2020
Date registered
8/10/2020
Date last updated
21/04/2021

Titles & IDs
Public title
Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Oral QPX7831 in Healthy Adult Subjects
Secondary ID [1] 0 0
Qpex-101
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 - QPX7831
Treatment: Drugs - placebo comparator

Experimental: QPX7831 SAD Cohorts - oral, single ascending dose (or placebo)

Experimental: QPX7831 MAD Cohorts - oral, multiple ascending dose (or placebo)


Treatment: Drugs: QPX7831
capsule

Treatment: Drugs: placebo comparator
oral matched placebo capsule

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 (single dose, multiple doses) - Number of patients with Treatment-Emergent AEs by subject, by cohort, severity and relationship to treatment
Timepoint [1] 0 0
up to 17 days
Primary outcome [2] 0 0
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 cohort
Timepoint [2] 0 0
up to 17 days
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
up to 17 days
Primary outcome [4] 0 0
Time concentration data measurements by subject and by cohort (Tmax) - Comparison will be performed between the cohorts for Tmax.
Timepoint [4] 0 0
up to 17 days
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
up to 17 days
Primary outcome [6] 0 0
Urine PK amount excreted by subject and by cohort - Urine PK parameters such as amount excreted will be calculated from urinary excretion data
Timepoint [6] 0 0
up to 17 days
Primary outcome [7] 0 0
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
Timepoint [7] 0 0
up to 17 days

Eligibility
Key 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).

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 use a condom when engaging in any sexual activity from
study check-in 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. Intra-uterine 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 with serum FSH levels = 40 mIU/mL are either
postmenopausal (defined as 12 months spontaneous amenorrhea) 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.
Minimum age
18 Years
Maximum age
55 Years
Gender
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 human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg), or hepatitis C antibodies (HCV).

4. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.

5. Use of more than 5 packs/week of cigarettes (or equivalent amount of
nicotine-containing product) within 6 months prior to Day 1. Subjects must agree to
refrain from smoking for the duration of the study.

6. 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.

7. Use of any prescription medication (with the exception of hormone replacement therapy
for females) within 14 days prior to Day 1.

8. 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 paracetamol
is allowed for acute events at the discretion of the PI.

9. Use of antacids, H2 receptor blockers or proton pump inhibitors within 7 days prior to
Day 1.

10. Documented hypersensitivity reaction or anaphylaxis to any medication

11. Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day

12. Plasma donation within 7 days prior to Day 1.

13. 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.

14. Females who are pregnant or lactating.

15. Surgery within the past three months prior to Day 1 determined by the PI to be
clinically relevant.

16. Any acute illness within 30 days prior to Day 1.

17. QTcF interval >450 msec for males and >470 for females or history of prolonged QT
syndrome at screening or check-in (Day -1).

18. Calculated creatinine clearance less than 80 mL/min (Cockcroft-Gault method) at
screening or check-in (Day -1).

19. Subjects who have any clinically significant abnormalities on laboratory values 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.

3. Liver function abnormalities at screening or check-in (Day -1) (defined by an
elevation in bilirubin, AST or ALT 1.5 x ULN of the normal range for subjects
based on age and sex).

20. Any other condition or prior therapy, which, in the opinion of the PI, would make the
subject unsuitable for this study.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
This Phase 1 study will assess the safety, tolerability, and pharmacokinetics (PK) of
QPX7831, a beta-lactamase inhibitor, when administered orally in single ascending doses and
in multiple ascending doses to heathy adult subjects.
Trial website
https://clinicaltrials.gov/show/NCT04578873
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffery 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
Elizabeth E Morgan
Address 0 0
Country 0 0
Phone 0 0
858-500-8388
Fax 0 0
Email 0 0
lmorgan@qpexbio.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04578873