Drug-drug InteractionPhase 1NCT04650542
Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects
A Phase 1 study testing HBI-3000 and Paroxetine in people with Drug-drug Interaction, run by HUYABIO International, LLC. at 2 sites in 2 countries.
Trial summary
Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction
- What is being tested?
- HBI-3000 and Paroxetine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Feb 2021to 13 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects
Read the 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
- Being tested
- HBI-3000, Paroxetine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBI-3000Drug
Also called Sulcardine sulfate
small molecule, multi-ion channel blocker
ParoxetineDrug
serotonin uptake inhibitor, CYP2D6 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: HBI-3000; Drug: Paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 72 hours
Secondary outcomes (9)
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.
Measured: 25 days
Routine hematology and coagulation
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by routine hematology and coagulation tests, at Screening and periodically during the study, including: Hematocrit (Packed cell volume); Hemoglobin; Lymphocytes; Mean cell hemoglobin Mean cell hemoglobin concentration; Mean cell volume; Basophils; Eosinophils; Monocytes; Neutrophils; Platelet count; Red blood cell count; White blood cell count; Coagulation Tests; Prothrombin time; International normalised ratio; Partial thromboplastin time
Measured: 25 days
Routine serum chemistry
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by routine serum clinical chemistry tests, at Screening and periodically during the study, including: Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Bicarbonate; Bilirubin (total); Bilirubin (direct); Calcium; Chloride; Cholesterol; Creatine kinase; Creatinine, estimated clearance; Gamma glutamyl transferase; Triglycerides; Globulin; A/G ratio; Glucose; Magnesium; Potassium; Phosphate (inorganic); Protein (total); Sodium; Urea; Uric acid
Measured: 25 days
Vitals signs
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by vitals signs including heart rate and blood pressure using an automated blood pressure device, at Screening and periodically during the study.
Measured: 25 days
12-lead ECG
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by 12-lead ECG. Twelve-lead ECGs will be measured at Screening and periodically during the study using standardized equipment provided by the core ECG laboratory and reviewed locally by the Investigator. QTc interval will be calculated from Fridericia's formula.
Measured: 25 days
Continuous telemetry
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by monitoring via a continuous cardiac telemetry monitoring system for 8 hours commencing with the start of HBI-3000 infusion
Measured: 8 hours beginning at the start of infusion
Infusion site (local) reactions
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by observing infusion site (local) reactions for the duration of the study (approximately 25 days) commencing with the start of HBI-3000 infusion
Measured: 25 days
Physical examination findings
To evaluate the safety and tolerability of HBI-3000 in the absence and the presence of paroxetine, as measured by examination of body systems and symptom directed examination as indicated, at Screening and during the study (approximately 25 days)
Measured: 25 days
Left ventricular ejection fraction (LVEF), Exploratory
To evaluate the safety and tolerability of HBI-3000 in the absence of paroxetine, as measured by 2D transthoracic echocardiogram to measure changes in cardiac contractility, determined at baseline and at 30 minutes and 2 hours after the start of infusion
Measured: At baseline and 2 hours beginning at the start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start21 Feb 2021
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- HUYABIO International, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Lickliter, MD, Principal investigator, Nucleus NetworkJennifer Deering, MSN, ARNP, Principal investigator, Spaulding Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650542
- Sponsor's protocol ID
- HBI-3000-401
- Status last verified
- Jul 2022
- First submitted
- 13 Nov 2020
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04650542
- Acronym / sponsor ID
- HBI-3000-401
- Conditions
- Drug-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- HUYABIO International, LLC.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| HBI-3000 alone (Period 1) followed by HBI-3000 with Paroxetine (Period 2) | Experimental | Drug: HBI-3000, Drug: ParoxetineHBI-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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBI-3000Also: Sulcardine sulfatesmall molecule, multi-ion channel blocker | Drug | HBI-3000 alone (Period 1) followed by HBI-3000 with Paroxetine (Period 2) |
| Paroxetineserotonin uptake inhibitor, CYP2D6 inhibitor | Drug | HBI-3000 alone (Period 1) followed by HBI-3000 with Paroxetine (Period 2) |
Primary outcome
Plasma pharmacokinetics (PK): Maximum observed plasma concentration (Cmax)
Time frame: 72 hours
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.
Plasma pharmacokinetics (PK): Area Under the Curve (AUC) from time 0 to last measurable concentration (AUC0 - tau)
Time frame: 72 hours
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.
Plasma pharmacokinetics (PK): Area Under the Curve (AUC) from time 0 to infinity (AUC0 - infinity), if data permits
Time frame: 72 hours
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.
9 secondary outcomes
Treatment-Emergent Adverse Events (TEAEs), including serious TEAEs
Time frame: 25 days
Routine hematology and coagulation
Time frame: 25 days
Routine serum chemistry
Time frame: 25 days
Vitals signs
Time frame: 25 days
12-lead ECG
Time frame: 25 days
Continuous telemetry
Time frame: 8 hours beginning at the start of infusion
Infusion site (local) reactions
Time frame: 25 days
Physical examination findings
Time frame: 25 days
Left ventricular ejection fraction (LVEF), Exploratory
Time frame: At baseline and 2 hours beginning at the start of infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Lickliter, MD principal investigator
Nucleus Network
Jennifer Deering, MSN, ARNP principal investigator
Spaulding Clinical
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBI-3000 and Paroxetine in people with Drug-drug Interaction, run by HUYABIO International, LLC. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma pharmacokinetics (PK): Maximum observed plasma concentration (Cmax) (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.