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

NCT04650542 | Completed Phase 1 FDA Drug

• 1 other identifier: HBI-3000-401
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Drug-drug Interaction

Outcome Measures

Primary Outcomes (3)

• Plasma pharmacokinetics (PK): Maximum observed plasma concentration (Cmax)

  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.

  72 hours

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

  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.

  72 hours

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

  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.

  72 hours

Secondary Outcomes (9)

• Treatment-Emergent Adverse Events (TEAEs), including serious TEAEs

  25 days

• Routine hematology and coagulation

  25 days

• Routine serum chemistry

  25 days

• Vitals signs

  25 days

• 12-lead ECG

  25 days

Study Arms (1)

HBI-3000 alone (Period 1) followed by HBI-3000 with Paroxetine (Period 2)

EXPERIMENTAL

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

Drug: HBI-3000; Drug: Paroxetine

Interventions

HBI-3000 DRUG

small molecule, multi-ion channel blocker

Also known as: Sulcardine sulfate

HBI-3000 alone (Period 1) followed by HBI-3000 with Paroxetine (Period 2)

Paroxetine DRUG

serotonin uptake inhibitor, CYP2D6 inhibitor

HBI-3000 alone (Period 1) followed by HBI-3000 with Paroxetine (Period 2)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males and females
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HUYABIO International, LLC.: lead

Study Sites (2)

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

Location

Nucleus Network Pty Ltd.

Melbourne, Victoria, Australia

Location

MeSH Terms

Interventions

sulcardine sulfate; Paroxetine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jason Lickliter, MD

  Nucleus Network

  PRINCIPAL INVESTIGATOR

• Jennifer Deering, MSN, ARNP

  Spaulding Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Parallel Assignment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * Experimental: 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

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 2, 2020
• Study Start: February 21, 2021
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (1)