Study to Evaluate the Drug-drug Interac… | Clinical Trial

Key information

Conditions

ADPKD (Autosomal Dominant Polycystic Kidney Disease) Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Fully understand the research content, process, and potential risks of this trial, voluntarily participate in the clinical trial and sign the informed consent,
Healthy male and female subjects aged ≥18 years and ≤45 years old, Male weight ≥50kg, female weight ≥45kg, body mass index ≥19 kg/m2 and ≤28 kg/m2,
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.

Exclusion criteria

HBV surface antigen, HCV antibody, HIV, or syphilis are positive during screening,
At the time of screening, the vital signs are within the following ranges: systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg, pulse <50 bpm or >100 bpm and ear temperature 37.5℃or<35℃,
More than 5 cigarettes per day during the 3 months prior to screening, Or were unable to quit smoking/containing tobacco products during the trial,
Have special requirements for diet and cannot comply with the diet provided and corresponding regulations.

Treatment and study plan

Cohort 1: JMKX003142 and itraconazole

Drug

JMKX003142: Dose: 3 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg itraconazole once: Day8, once only in the morning.

Itraconazole：Dose: 200mg once；Day5-Day7 and Day9-Day11, QD

Cohort 2: JMKX003142 and rifampicin

Drug

JMKX003142: Dose: 6 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg rifampicin once: Day14, once only in the morning.

Rifampicin：Dose: 600mg once；Day5-Day13 and Day15-Day17, QD

Primary outcomes

Cmax of JMKX003142 in plasma

Time frame: approximately 5 days after JMKX003142 administered

Cmax of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin
AUC of JMKX003142 in plasma

Time frame: approximately 5 days after JMKX003142 administered

AUC of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin

Study contacts

Contact information is provided by the study sponsor or research team.

Jianping Su

CONTACT

[email protected]

86+15162481262

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Collaborators

Zhejiang Hangyu Pharmaceutical Co., Ltd.

Registry information

Official study title

A Single-center, Non-randomized, Open-label, Self-controlled Phase 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX003142 Tablets in Healthy Subjects

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Oct 26, 2024
Registry last updated: Oct 26, 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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