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

HUYABIO International, LLC.39 enrolled

Overview

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug-drug Interaction

Interventions

HBI-3000DRUG

small molecule, multi-ion channel blocker

ParoxetineDRUG

serotonin uptake inhibitor, CYP2D6 inhibitor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Spaulding Clinical

West Bend, Wisconsin, United States

Nucleus Network Pty Ltd.

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 72 hours

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

Time frame: 72 hours

Secondary Outcomes

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

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.

Data from ClinicalTrials.gov

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