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

NCT06658964 | Not Yet Recruiting Phase 1

• 1 other identifier: JMKX003142-102
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (2)

• Cmax of JMKX003142 in plasma

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

  approximately 5 days after JMKX003142 administered

• AUC of JMKX003142 in plasma

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

  approximately 5 days after JMKX003142 administered

Study Arms (2)

Cohort 1：JMKX003142 and itraconazole

EXPERIMENTAL

Interaction between JMKX003142 and itraconazole

Drug: Cohort 1: JMKX003142 and itraconazole

Cohort 2：JMKX003142 and rifampicin

EXPERIMENTAL

Interaction between JMKX003142 and rifampicin

Drug: Cohort 2: JMKX003142 and rifampicin

Interventions

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 1：JMKX003142 and itraconazole

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

Cohort 2：JMKX003142 and rifampicin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead
• Zhejiang Hangyu Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

Itraconazole; Rifampin

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Leilei Zhu

  Shuguang Hospital Affiliated with Shanghai University of TCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianping Su

CONTACT

86+15162481262; sujianping@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: November 5, 2024
• Primary Completion: December 10, 2024
• Study Completion: March 21, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10