Clinical trial NCT06354556: Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center, open, single arm, fixed sequence
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose
timeFrame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
measure: Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose
timeFrame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
measure: Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose
timeFrame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
Secondary outcomes:
measure: Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose
timeFrame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
measure: Elimination half-life (T1/2) for HRS-1893 after single dose
timeFrame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
measure: Apparent oral clearance (CL/F) for HRS-1893 after single dose
timeFrame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
measure: Apparent volume of distribution (Vz/F) for HRS-1893 after single dose
timeFrame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
measure: Accumulated amount of excretion (Ae) for HRS-1893 after single dose
timeFrame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
measure: Urinary excretion fraction（fe）for HRS-1893 after single dose
timeFrame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
measure: Renal clearance（CLr）for HRS-1893 after single dose
timeFrame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose
measure: Number of subjects with adverse events and the severity of adverse events
timeFrame: from Day 1 to Day 24 after the first dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
References: