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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Intervention / Treatment: Drug: HRS-1893 tablet; Drug: Verapamil tablet

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Meng Fu; Phone Number: +86 0518-82342973; Email: meng.fu@hengrui.com
• Study Contact Backup: Name: Sheng Feng; Phone Number: +86 0518-82342973; Email: sheng.feng@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital
      • Contact: Yang Lin, Doctor; Phone Number: 010-64456045; Email: linyang@anzhengcp.com
      • Contact: Shan Jin, Doctor; Phone Number: 010-64456045; Email: jingshan@anzhengcp.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm	Drug: HRS-1893 tablet; HRS-1893 tablet single dose; Drug: Verapamil tablet; Verapamil tablet 80 mg tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Time Frame
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
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
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
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
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
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
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
Number of subjects with adverse events and the severity of adverse events	from Day 1 to Day 24 after the first dose

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2024
• Primary Completion (Estimated): May 5, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Verapamil
• Other Study ID Numbers: HRS-1893-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No