Phase 1 Study of Oral QPX2015 in Healthy Adult Subjects

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939429
• Other study ID #: Qpex-100
• Status: Completed
• Phase: Phase 1
• Start date: May 20, 2019
• Est. completion date: October 6, 2019

Study information

• Verified date: May 2019
• Source: Qpex Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 6, 2019
• Est. primary completion date: October 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• QPX2015
antibiotic
• Placebo oral capsule
Placebo comparator

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Qpex Biopharma, Inc.	Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Time concentration data measurements by subject and by cohort (Tmax)	Comparison will be performed between the cohorts for Tmax.	Study Day 1 to 13
Primary	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
Primary	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
Primary	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