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

ConditionADPKD (autosomal Dominant Polycystic Kidney Disease)

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-45

SponsorJemincare

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

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

Treatment groups

48 Participants

are divided into 2 treatment groups

Group A: Cohort 1：JMKX003142 and itraconazoleExperimental treatment 1 intervention

Group B: Cohort 2：JMKX003142 and rifampicinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Cmax of JMKX003142 in plasma

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

Time frame

approximately 5 days after JMKX003142 administered

AUC of JMKX003142 in plasma

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

Time frame

approximately 5 days after JMKX003142 administered

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jemincare

Lead sponsor

Zhejiang Hangyu Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: