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

NCT ID: NCT04650542

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-21
• Study Completion Date: 2021-08-13

Brief Summary

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

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.

Conditions

Drug-drug Interaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

HBI-3000

Intervention Type: DRUG

small molecule, multi-ion channel blocker

Paroxetine

Intervention Type: DRUG

serotonin uptake inhibitor, CYP2D6 inhibitor

Interventions

HBI-3000

small molecule, multi-ion channel blocker

Intervention Type: DRUG

Paroxetine

serotonin uptake inhibitor, CYP2D6 inhibitor

Intervention Type: DRUG

Other Intervention Names

Sulcardine sulfate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HUYABIO International, LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Lickliter, MD

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network

Jennifer Deering, MSN, ARNP

Role: PRINCIPAL_INVESTIGATOR

Spaulding Clinical

Locations

Spaulding Clinical

West Bend, Wisconsin, United States

Nucleus Network Pty Ltd.

Melbourne, Victoria, Australia

Countries

United States; Australia

Other Identifiers

HBI-3000-401

Identifier Type: -

Identifier Source: org_study_id