Clinical trial NCT04650542: Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-drug Interaction
Lead sponsor: HUYABIO International, LLC.
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: * 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Plasma pharmacokinetics (PK): Maximum observed plasma concentration (Cmax)
timeFrame: 72 hours
measure: Plasma pharmacokinetics (PK): Area Under the Curve (AUC) from time 0 to last measurable concentration (AUC0 - tau)
timeFrame: 72 hours
measure: Plasma pharmacokinetics (PK): Area Under the Curve (AUC) from time 0 to infinity (AUC0 - infinity), if data permits
timeFrame: 72 hours
Secondary outcomes:
measure: Treatment-Emergent Adverse Events (TEAEs), including serious TEAEs
timeFrame: 25 days
measure: Routine hematology and coagulation
timeFrame: 25 days
measure: Routine serum chemistry
timeFrame: 25 days
measure: Vitals signs
timeFrame: 25 days
measure: 12-lead ECG
timeFrame: 25 days
measure: Continuous telemetry
timeFrame: 8 hours beginning at the start of infusion
measure: Infusion site (local) reactions
timeFrame: 25 days
measure: Physical examination findings
timeFrame: 25 days
measure: Left ventricular ejection fraction (LVEF), Exploratory
timeFrame: At baseline and 2 hours beginning at the start of infusion
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical
state: Wisconsin
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd.
state: Victoria
Study officials:
affiliation: Nucleus Network
name: Jason Lickliter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spaulding Clinical
name: Jennifer Deering, MSN, ARNP
role: PRINCIPAL_INVESTIGATOR
References: