Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects

Obstructive Hypertrophic Cardiomyopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06354556
• Other study ID #: HRS-1893-102
• Status: Recruiting
• Phase: Phase 1
• Start date: April 26, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Shandong Suncadia Medicine Co., Ltd.
• Contact: Meng Fu
• Phone: +86 0518-82342973
• Email: meng.fu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: May 30, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF).

2. Male or female aged 18-55(adult healthy volunteers).

3. Body mass index (BMI) between 19 and 28 kg/m2.

4. Normal Electrocardiogram (ECG).

Exclusion Criteria:

1. History of persistent tachyarrhythmia and syncope.

2. A history of stomach or bowel surgery or excision.

3. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.

4. Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Obstructive Hypertrophic Cardiomyopathy

Intervention

Drug:
• HRS-1893 tablet
HRS-1893 tablet single dose
• Verapamil tablet
Verapamil tablet 80 mg tid

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Suncadia Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose		from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Primary	Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose		from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Primary	Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose		from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Secondary	Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose		from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Secondary	Elimination half-life (T1/2) for HRS-1893 after single dose		from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Secondary	Apparent oral clearance (CL/F) for HRS-1893 after single dose		from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Secondary	Apparent volume of distribution (Vz/F) for HRS-1893 after single dose		from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Secondary	Accumulated amount of excretion (Ae) for HRS-1893 after single dose		from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Secondary	Urinary excretion fraction(fe)for HRS-1893 after single dose		from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Secondary	Renal clearance(CLr)for HRS-1893 after single dose		from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Secondary	Number of subjects with adverse events and the severity of adverse events		from Day 1 to Day 24 after the first dose