Obstructive Hypertrophic Cardiomyopathy
Conditions
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.
Interventions
DRUGHRS-1893 tablet
HRS-1893 tablet single dose
DRUGVerapamil tablet
Verapamil tablet 80 mg tid
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single center, open, single arm, fixed sequence
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed