Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults

NCT04578873 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: Qpex-101
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 2

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.

Conditions

Bacterial Infections

Keywords

beta-lactamase inhibitor

Outcome Measures

Primary Outcomes (7)

• 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

  up to 17 days

• 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

  up to 17 days

• 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.

  up to 17 days

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

  Comparison will be performed between the cohorts for Tmax.

  up to 17 days

• 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.

  up to 17 days

• Urine PK amount excreted by subject and by cohort

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

  up to 17 days

• 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

  up to 17 days

Study Arms (2)

QPX7831 SAD Cohorts

EXPERIMENTAL

oral, single ascending dose (or placebo)

Drug: QPX7831; Drug: placebo comparator

QPX7831 MAD Cohorts

EXPERIMENTAL

oral, multiple ascending dose (or placebo)

Drug: QPX7831; Drug: placebo comparator

Interventions

QPX7831 DRUG

capsule

QPX7831 MAD Cohorts; QPX7831 SAD Cohorts

placebo comparator DRUG

oral matched placebo capsule

QPX7831 MAD Cohorts; QPX7831 SAD Cohorts

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-childbearing potential, 18 to 55 years of age (inclusive) at the time of screening.
• 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.
• 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:
• 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.
• Barrier method (diaphragm) for at least 14 days prior to Day 1 through 30 days following dosing of the study drug.
• Stable hormonal contraceptive for at least 3 months prior to Day 1 through 30 days following dosing of the study drug.
• Surgical sterilization (vasectomy) at least 6 months prior to Day 1.
• 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):
• Bilateral tubal ligation;
• Hysterectomy;
• Hysterectomy with unilateral or bilateral oophorectomy;
• Bilateral oophorectomy.

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 human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
• History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
• 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.
• 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.
• Use of any prescription medication (with the exception of hormone replacement therapy for females) within 14 days prior to Day 1.
• 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.
• Use of antacids, H2 receptor blockers or proton pump inhibitors within 7 days prior to Day 1.
• Documented hypersensitivity reaction or anaphylaxis to any medication
• Blood donation or significant blood loss (i.e., \> 500 mL) within 56 days prior to Day
• Plasma donation within 7 days prior to Day 1.
• 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.
• Females who are pregnant or lactating.
• Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant.

Sponsors & Collaborators

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

Study Sites (2)

Altasciences

Cypress, California, 90630, United States

Location

CMAX

Adelaide, South Australia, Australia

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Jeffery Loutit, MBChB

  Qpex Biopharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: matched oral placebo capsule
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, sequential, ascending single-and multiple-dose design

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 8, 2020
• Study Start: April 13, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); AU (1)