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

Phase 1

Not yet recruiting

• Conditions: ADPKD (autosomal Dominant Polycystic Kidney Disease)

• Registration Number: NCT06658964
• Lead Sponsor: Jemincare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Last Update Submitted: 2024-10-23
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Study Start: 2024-11-05
• Primary Completion: 2024-12-10
• Study Completion: 2025-03-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cmax of JMKX003142 in plasma	approximately 5 days after JMKX003142 administered	Cmax of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin
AUC of JMKX003142 in plasma	approximately 5 days after JMKX003142 administered	AUC of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin