Obstructive Hypertrophic CardiomyopathyPhase 1NCT06354556
Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects
A Phase 1 study testing HRS-1893 tablet and Verapamil tablet in people with Obstructive Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- HRS-1893 tablet and Verapamil tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2024to 20 May 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF).
- Male or female aged 18-55（adult healthy volunteers).
- Body mass index (BMI) between 19 and 28 kg/m2.
- Normal Electrocardiogram (ECG).
Who cannot join
- History of persistent tachyarrhythmia and syncope.
- A history of stomach or bowel surgery or excision.
- Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
- Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Verapamil on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects: a Single Center, Open, Single Arm, and Fixed Sequence Study
The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects.
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Being tested
- HRS-1893 tablet, Verapamil tablet
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1893 tabletDrug
HRS-1893 tablet single dose
Verapamil tabletDrug
Verapamil tablet 80 mg tid
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Drug: HRS-1893 tablet; Drug: Verapamil tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose
Measured: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose
Measured: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose
Measured: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Secondary outcomes (8)
Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose
Measured: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Elimination half-life (T1/2) for HRS-1893 after single dose
Measured: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Apparent oral clearance (CL/F) for HRS-1893 after single dose
Measured: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Apparent volume of distribution (Vz/F) for HRS-1893 after single dose
Measured: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Accumulated amount of excretion (Ae) for HRS-1893 after single dose
Measured: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Urinary excretion fraction（fe）for HRS-1893 after single dose
Measured: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Renal clearance（CLr）for HRS-1893 after single dose
Measured: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Number of subjects with adverse events and the severity of adverse events
Measured: from Day 1 to Day 24 after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start26 Apr 2024
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Single center, open, single arm, fixed sequence
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354556
- Sponsor's protocol ID
- HRS-1893-102
- Status last verified
- Jun 2024
- First submitted
- 3 Apr 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Verapamil on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects: a Single Center, Open, Single Arm, and Fixed Sequence Study
- ClinicalTrials.gov ID
- NCT06354556
- Acronym / sponsor ID
- HRS-1893-102
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 9 Apr 2024 (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.
The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, open, single arm, fixed sequence
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: HRS-1893 tablet, Drug: Verapamil tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF).
- Male or female aged 18-55（adult healthy volunteers).
- Body mass index (BMI) between 19 and 28 kg/m2.
- Normal Electrocardiogram (ECG).
Key exclusion criteria (4 listed)
- History of persistent tachyarrhythmia and syncope.
- A history of stomach or bowel surgery or excision.
- Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
- Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration.
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 |
|---|---|---|
| HRS-1893 tabletHRS-1893 tablet single dose | Drug | Single arm |
| Verapamil tabletVerapamil tablet 80 mg tid | Drug | Single arm |
Primary outcome
Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose
Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose
Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose
Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
8 secondary outcomes
Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose
Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Elimination half-life (T1/2) for HRS-1893 after single dose
Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Apparent oral clearance (CL/F) for HRS-1893 after single dose
Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Apparent volume of distribution (Vz/F) for HRS-1893 after single dose
Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Accumulated amount of excretion (Ae) for HRS-1893 after single dose
Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Urinary excretion fraction（fe）for HRS-1893 after single dose
Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Renal clearance（CLr）for HRS-1893 after single dose
Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Number of subjects with adverse events and the severity of adverse events
Time frame: from Day 1 to Day 24 after the first dose
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 6 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Hypertrophic Cardiomyopathy
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
Hypertrophic Cardiomyopathy
Not yet recruitingPhase 4
Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Nonobstructive Hypertrophic Cardiomyopathy
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
Active, not recruitingPhase 3
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-1893 tablet and Verapamil tablet in people with Obstructive Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
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 4 inclusion and 4 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 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose (time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose). 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 6 Jun 2024.