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Completed

NCT Number: NCT06354556

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

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.

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Key information

Conditions

Obstructive Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

HRS-1893 Tablet

Drug

HRS-1893 tablet single dose

Verapamil tablet

Drug

Verapamil tablet 80 mg tid

Primary outcomes

  1. Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose

    Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose

  2. Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose

    Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose

  3. Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose

    Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose

Secondary outcomes

  1. Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose

    Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose

  2. Elimination half-life (T1/2) for HRS-1893 after single dose

    Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose

  3. Apparent oral clearance (CL/F) for HRS-1893 after single dose

    Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose

  4. Apparent volume of distribution (Vz/F) for HRS-1893 after single dose

    Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose

  5. Accumulated amount of excretion (Ae) for HRS-1893 after single dose

    Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose

  6. Urinary excretion fraction（fe）for HRS-1893 after single dose

    Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose

  7. Renal clearance（CLr）for HRS-1893 after single dose

    Time frame: from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose

  8. Number of subjects with adverse events and the severity of adverse events

    Time frame: from Day 1 to Day 24 after the first dose

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

Effect of Verapamil on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects: a Single Center, Open, Single Arm, and Fixed Sequence Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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