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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04650542




Registration number
NCT04650542
Ethics application status
Date submitted
13/11/2020
Date registered
2/12/2020

Titles & IDs
Public title
Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects
Scientific title
Open-Label, Two-Period Phase 1 Study in Healthy Subjects to Evaluate the Potential Effect of Multiple Doses of Paroxetine on the Pharmacokinetics and Safety of HBI-3000
Secondary ID [1] 0 0
HBI-3000-401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug-drug Interaction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HBI-3000
Treatment: Drugs - Paroxetine

Experimental: HBI-3000 alone (Period 1) followed by HBI-3000 with Paroxetine (Period 2) - HBI-3000: 350 mg, 50 mL intravenous infusion (IV) over 30 minutes on Day 1 of Period 1 and approximately 15 days later on Day 1 of Period 2

Paroxetine: 20 mg dose twice a day on Days 1 and 2 of Period 2, and once a day on Days 3 through 7 inclusive of Period 2


Treatment: Drugs: HBI-3000
small molecule, multi-ion channel blocker

Treatment: Drugs: Paroxetine
serotonin uptake inhibitor, CYP2D6 inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma pharmacokinetics (PK): Maximum observed plasma concentration (Cmax)
Assessment method [1] 0 0
To determine the plasma Cmax of a single dose of HBI 3000 administered intravenously (IV), in the absence and the presence of CYP2D6 inhibition, achieved with multiple oral doses of paroxetine, a strong CYP2D6 inhibitor, in healthy male and female subjects. Blood samples will be taken from 0 through 72 hours after the start of HBI-3000 infusion.
Timepoint [1] 0 0
72 hours
Primary outcome [2] 0 0
Plasma pharmacokinetics (PK): Area Under the Curve (AUC) from time 0 to last measurable concentration (AUC0 - tau)
Assessment method [2] 0 0
To determine the plasma AUC of a single dose of HBI 3000 administered intravenously (IV), in the absence and the presence of CYP2D6 inhibition, achieved with multiple oral doses of paroxetine, a strong CYP2D6 inhibitor, in healthy male and female subjects. Blood samples will be taken from 0 through 72 hours after the start of HBI-3000 infusion.
Timepoint [2] 0 0
72 hours
Primary outcome [3] 0 0
Plasma pharmacokinetics (PK): Area Under the Curve (AUC) from time 0 to infinity (AUC0 - infinity), if data permits
Assessment method [3] 0 0
To determine the plasma AUC of a single dose of HBI 3000 administered intravenously (IV), in the absence and the presence of CYP2D6 inhibition, achieved with multiple oral doses of paroxetine, a strong CYP2D6 inhibitor, in healthy male and female subjects. Blood samples will be taken from 0 through 72 hours after the start of HBI-3000 infusion.
Timepoint [3] 0 0
72 hours
Secondary outcome [1] 0 0
Treatment-Emergent Adverse Events (TEAEs), including serious TEAEs
Assessment method [1] 0 0
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by Treatment-Emergent Adverse Events (TEAEs), including serious TEAEs. TEAE is defined as follows: An AE that emerges during treatment, having been absent at pretreatment (Baseline), an AE that re emerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or an AE that worsens in severity during treatment relative to the pretreatment state, when the AE is ongoing. TEAEs will be recorded for approximately 25 days commencing with the start of HBI-3000 infusion.
Timepoint [1] 0 0
25 days
Secondary outcome [2] 0 0
Routine hematology and coagulation
Assessment method [2] 0 0
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by routine hematology and coagulation tests, at Screening and periodically during the study, including: Hematocrit (Packed cell volume); Hemoglobin; Lymphocytes; Mean cell hemoglobin Mean cell hemoglobin concentration; Mean cell volume; Basophils; Eosinophils; Monocytes; Neutrophils; Platelet count; Red blood cell count; White blood cell count; Coagulation Tests; Prothrombin time; International normalised ratio; Partial thromboplastin time
Timepoint [2] 0 0
25 days
Secondary outcome [3] 0 0
Routine serum chemistry
Assessment method [3] 0 0
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by routine serum clinical chemistry tests, at Screening and periodically during the study, including: Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Bicarbonate; Bilirubin (total); Bilirubin (direct); Calcium; Chloride; Cholesterol; Creatine kinase; Creatinine, estimated clearance; Gamma glutamyl transferase; Triglycerides; Globulin; A/G ratio; Glucose; Magnesium; Potassium; Phosphate (inorganic); Protein (total); Sodium; Urea; Uric acid
Timepoint [3] 0 0
25 days
Secondary outcome [4] 0 0
Vitals signs
Assessment method [4] 0 0
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by vitals signs including heart rate and blood pressure using an automated blood pressure device, at Screening and periodically during the study.
Timepoint [4] 0 0
25 days
Secondary outcome [5] 0 0
12-lead ECG
Assessment method [5] 0 0
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by 12-lead ECG. Twelve-lead ECGs will be measured at Screening and periodically during the study using standardized equipment provided by the core ECG laboratory and reviewed locally by the Investigator. QTc interval will be calculated from Fridericia's formula.
Timepoint [5] 0 0
25 days
Secondary outcome [6] 0 0
Continuous telemetry
Assessment method [6] 0 0
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by monitoring via a continuous cardiac telemetry monitoring system for 8 hours commencing with the start of HBI-3000 infusion
Timepoint [6] 0 0
8 hours beginning at the start of infusion
Secondary outcome [7] 0 0
Infusion site (local) reactions
Assessment method [7] 0 0
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by observing infusion site (local) reactions for the duration of the study (approximately 25 days) commencing with the start of HBI-3000 infusion
Timepoint [7] 0 0
25 days
Secondary outcome [8] 0 0
Physical examination findings
Assessment method [8] 0 0
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by examination of body systems and symptom directed examination as indicated, at Screening and during the study (approximately 25 days)
Timepoint [8] 0 0
25 days
Secondary outcome [9] 0 0
Left ventricular ejection fraction (LVEF), Exploratory
Assessment method [9] 0 0
To evaluate the safety and tolerability of HBI-3000 in the absence of paroxetine, as measured by 2D transthoracic echocardiogram to measure changes in cardiac contractility, determined at baseline and at 30 minutes and 2 hours after the start of infusion
Timepoint [9] 0 0
At baseline and 2 hours beginning at the start of infusion

Eligibility
Key inclusion criteria
Healthy adult males and females

* 18 - 50 years of age
* BMI 18 - 32 kg/m2
* Subject has no clinically significant abnormality on electrocardiogram (ECG)
* Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 4 months
* Subject is willing to comply with the study restrictions, including contraception requirements
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Evidence of a clinically significant disease or abnormalities, including an active, current infection or clinically significant infection within 8 weeks prior to the first dose
* Severe allergic reaction, angioedema, or anaphylaxis to drugs, or food or latex allergies
* Subject has an estimated creatinine clearance of = 70 mL
* Subject has evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations
* Subject has significant ECG abnormality, history or presence of cardiac arrhythmia or conduction abnormalities, or bradycardia (< 45 bpm)
* Subject has a history of vasovagal syncope, or symptomatic orthostatic hypotension
* Subject has as a history of or current alcohol abuse and/or other drug addiction
* Subject has received an investigational drug (including investigational vaccines) within 5 half-lives of such drug prior to Study Day 1
* Subject has received CYP2D inhibitors (e.g., fluoxetine, sertraline, duloxetine, bupropion, chloroquine, cimetidine, diphenhydramine) less than 3 weeks prior to administration of the initial dose of study drug
* Subject has suicidal thinking and behavior (suicidality) or other significant psychiatric disorders based on self-disclosure during interview (Screening visit)
* Subject has a history of acute narrow-angle glaucoma
* Subject has as any condition that would make him or her, in the opinion of the Investigator or Sponsor, unsuitable for the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
21/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/08/2021
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
HUYABIO International, LLC.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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/NCT04650542