Study to Evaluate the Drug-drug Interaction of JMKX003142 in Healthy Subjects

Jemincare

Status and phase: Not yet enrolling; Phase 1

Conditions: ADPKD (autosomal Dominant Polycystic Kidney Disease)

Treatments: Drug: Cohort 2: JMKX003142 and rifampicin; Drug: Cohort 1: JMKX003142 and itraconazole

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06658964

JMKX003142-102

Details and patient eligibility

About

To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Cohort 1：JMKX003142 and itraconazole

Experimental group

Description:

Interaction between JMKX003142 and itraconazole

Treatment:

Drug: Cohort 1: JMKX003142 and itraconazole

Cohort 2：JMKX003142 and rifampicin

Experimental group

Description:

Interaction between JMKX003142 and rifampicin

Treatment:

Drug: Cohort 2: JMKX003142 and rifampicin