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

Phase 1

Completed

• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Interventions: Drug: HRS-1893 tablet; Drug: Verapamil tablet

• Registration Number: NCT06354556
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-09
• Study Start: 2024-04-26
• Primary Completion: 2024-05-20
• Study Completion: 2024-05-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	HRS-1893 tablet	-
Single arm	Verapamil tablet	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China