- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04650542
Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects
July 14, 2022 updated by: HUYABIO International, LLC.
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
Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Melbourne, Victoria, Australia
- Nucleus Network Pty Ltd.
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Wisconsin
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West Bend, Wisconsin, United States, 53095
- Spaulding Clinical
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 |
small molecule, multi-ion channel blocker
Other Names:
serotonin uptake inhibitor, CYP2D6 inhibitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma pharmacokinetics (PK): Maximum observed plasma concentration (Cmax)
Time Frame: 72 hours
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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.
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72 hours
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Plasma pharmacokinetics (PK): Area Under the Curve (AUC) from time 0 to last measurable concentration (AUC0 - tau)
Time Frame: 72 hours
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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.
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72 hours
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Plasma pharmacokinetics (PK): Area Under the Curve (AUC) from time 0 to infinity (AUC0 - infinity), if data permits
Time Frame: 72 hours
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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.
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72 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-Emergent Adverse Events (TEAEs), including serious TEAEs
Time Frame: 25 days
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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.
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25 days
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Routine hematology and coagulation
Time Frame: 25 days
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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
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25 days
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Routine serum chemistry
Time Frame: 25 days
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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
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25 days
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Vitals signs
Time Frame: 25 days
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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.
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25 days
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12-lead ECG
Time Frame: 25 days
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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.
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25 days
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Continuous telemetry
Time Frame: 8 hours beginning at the start of infusion
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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
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8 hours beginning at the start of infusion
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Infusion site (local) reactions
Time Frame: 25 days
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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
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25 days
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Physical examination findings
Time Frame: 25 days
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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)
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25 days
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Left ventricular ejection fraction (LVEF), Exploratory
Time Frame: At baseline and 2 hours beginning at the start of infusion
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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
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At baseline and 2 hours beginning at the start of infusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Deering, MSN, ARNP, Spaulding Clinical
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2021
Primary Completion (Actual)
August 13, 2021
Study Completion (Actual)
August 13, 2021
Study Registration Dates
First Submitted
November 13, 2020
First Submitted That Met QC Criteria
December 1, 2020
First Posted (Actual)
December 2, 2020
Study Record Updates
Last Update Posted (Actual)
July 15, 2022
Last Update Submitted That Met QC Criteria
July 14, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Paroxetine
Other Study ID Numbers
- HBI-3000-401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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