Skip to main content
OpenTrials
Completed

NCT Number: NCT04650542

Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects

Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Drug-drug Interaction

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Pty Ltd., Melbourne, Victoria, Australia

Loading trial locations.

About this study

This is a Phase 1 study in healthy volunteers to evaluate the potential effect of multiple doses of paroxetine on the pharmacokinetics and safety of HBI-3000. Each subject serves as his/her own control: Period 1 vs. Period 2.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

HBI-3000

Drug

small molecule, multi-ion channel blocker

Other names: Sulcardine sulfate

paroxetine

Drug

serotonin uptake inhibitor, CYP2D6 inhibitor

Primary outcomes

  1. Plasma pharmacokinetics (PK): Maximum observed plasma concentration (Cmax)

    Time frame: 72 hours

    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.

  2. Plasma pharmacokinetics (PK): Area Under the Curve (AUC) from time 0 to last measurable concentration (AUC0 - tau)

    Time frame: 72 hours

    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.

  3. Plasma pharmacokinetics (PK): Area Under the Curve (AUC) from time 0 to infinity (AUC0 - infinity), if data permits

    Time frame: 72 hours

    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.

Secondary outcomes

  1. Treatment-Emergent Adverse Events (TEAEs), including serious TEAEs

    Time frame: 25 days

    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.

  2. Routine hematology and coagulation

    Time frame: 25 days

    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

  3. Routine serum chemistry

    Time frame: 25 days

    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

  4. Vitals signs

    Time frame: 25 days

    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.

  5. 12-lead ECG

    Time frame: 25 days

    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.

  6. Continuous telemetry

    Time frame: 8 hours beginning at the start of infusion

    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

  7. Infusion site (local) reactions

    Time frame: 25 days

    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

  8. Physical examination findings

    Time frame: 25 days

    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)

  9. Left ventricular ejection fraction (LVEF), Exploratory

    Time frame: At baseline and 2 hours beginning at the start of infusion

    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

Sponsors and collaborators

Lead sponsor

HUYABIO International, LLC.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.