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

NCT06354556 | Completed Phase 1

• 1 other identifier: HRS-1893-102
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: HRS-1893 tablet; Drug: Verapamil tablet

Interventions

HRS-1893 tablet DRUG

HRS-1893 tablet single dose

Single arm

Verapamil tablet DRUG

Verapamil tablet 80 mg tid

Single arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Verapamil

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, open, single arm, fixed sequence

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: April 26, 2024
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

CN (1)