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Not yet recruiting NCT07181265

Drug-Drug Interaction of JMKX003142 With Amiodarone and Febuxostat in Healthy Subjects

Phase I Interventional Autosomal Dominant Polycystic Kidney Disease (ADPKD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amiodarone Hydrochloride Tablets, Febuxostat Tablets.
Who it may be relevant to
Registry conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD). Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-center, Non-randomized, Open-label, Self-controlled Phase I Drug-drug Interaction Clinical Study to Evaluate the Pharmacokinetics of JMKX003142 With Amiodarone, and Febuxostat in Chinese Healthy Subjects

Overview

This is a open-label, non-randomized, multiple oral dosings, three-period, drug-drug interaction study of JMKX003142 tablet, Amiodarone Hydrochloride Tablets and Febuxostat Tablets in Chinese healthy adult subjects

Interventions

  • Drug Amiodarone Hydrochloride Tablets
    Cohort 1: The intervention is for study of drug drug interaction of JMKX003142 when administered with Amiodarone
  • Drug Febuxostat Tablets
    Cohort 2: The intervention is for study of drug drug interaction of JMKX003142 when administered with Febuxostat Tablets

Primary outcome measures

  • Cmax，ss [Time frame: up to 7 days]
  • AUC0-tau [Time frame: up tp 7 days]
Secondary outcome measures (2)
  • Tmax [Time frame: up to 7 days]
  • AUC0-t [Time frame: up to 7 days]

Eligibility criteria

Inclusion criteria

  • Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
  • Healthy adult males and/or females, 18 to 45 years of age (inclusive) at the date of signed consent form. Body mass index (BMI) greater than or equal to 18 and less than 32 (kg/m2) and a minimum body weight of 45 kg.
  • The health of the subjects was determined by the investigator based on medical history, physical examination, clinical laboratory examination, and 12-lead electrocardiogram, all of which were determined by the investigator to be normal or not clinically significant.
  • Women of child-bearing potential and sexually active males willing to use highly effective methods of contraception from screening until 3 months after last dose of study drug. In addition, participants must not donate sperm/egg for the time period specified above.

Exclusion criteria

  • Subjects having hypersensitivity to study drug or have a history of allergies to multiple drugs, foods, or other substances
  • History or presence of significant circulatory system, respiratory system, digestive system, blood system, urinary and reproductive system, endocrine and metabolic system, nervous system, mental system, muscular and skeletal system, skin system, lymphatic system, immune system, Otolaryngology or other related systems disease or disorder. as well as systemic or local acute or chronic infections.
  • Subjects with dysphagia, gastrointestinal diseases, or any conditions that may affect drug absorption; such as a history of hepatobiliary and pancreatic diseases, gastrointestinal diseases, gastrointestinal surgery (except appendectomy), or a history of chronic pancreatitis, idiopathic acute pancreatitis, or habitual diarrhea.
  • Vital signs during the screening period meet any of the following conditions: systolic blood pressure >140 mmHg or <90 mmHg; diastolic blood pressure >90 mmHg or <50 mmHg (Cohort 1: diastolic blood pressure >90 mmHg or <60 mmHg); pulse >100 beats/min or <50 beats/min (Cohort 1: pulse >100 beats/min or <60 beats/min); ear temperature >37.5°C or <35°C.
  • History of QTc interval prolongation or abnormal ECG results during screening, QTcF ≥ 450 ms for males or ≥ 470 ms for females, or QRS interval > 120 ms.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07181265 · JMKX003142-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗