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

NCT ID: NCT06658964

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2025-03-21

Brief Summary

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

Conditions

ADPKD (autosomal Dominant Polycystic Kidney Disease)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1：JMKX003142 and itraconazole

Interaction between JMKX003142 and itraconazole

Group Type: EXPERIMENTAL

Cohort 1: JMKX003142 and itraconazole

Intervention Type: 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

Interaction between JMKX003142 and rifampicin

Group Type: EXPERIMENTAL

Cohort 2: JMKX003142 and rifampicin

Intervention Type: 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

Interventions

Cohort 1: JMKX003142 and itraconazole

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

Intervention Type: DRUG

Cohort 2: JMKX003142 and rifampicin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Hangyu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jemincare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leilei Zhu

Role: PRINCIPAL_INVESTIGATOR

Shuguang Hospital Affiliated with Shanghai University of TCM

Central Contacts

Jianping Su

Role: CONTACT

sujianping@jemincare.com

86+15162481262

Other Identifiers

JMKX003142-102

Identifier Type: -

Identifier Source: org_study_id