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

Completed · Phase 1

Conditions studied: Drug-drug Interaction

In brief

Key facts

Study ID: NCT04650542
Run by: HUYABIO International, LLC.
People needed: 39
Starts: 2021-02-21
Expected to finish: 2021-08-13
Last updated by the study team: 2022-07-15

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

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

Where it is running

Spaulding Clinical — West Bend, Wisconsin, United States
Nucleus Network Pty Ltd. — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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