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Drug-Drug Interactions of JMKX003142 in Healthy Participants

ConditionADPKD (Autosomal Dominant Polycystic Kidney Disease)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJemincare

About this trial

This is a single-center, non-randomized, open-label, self-controlled, Phase I clinical trial to evaluate the drug-drug interactions (DDI) of JMKX003142 tablets in healthy adult participants.

The study consists of five cohorts (Cohorts 1, 2, 3, 4, and 5). A total of 24 participants are planned enrollment in each of Cohorts 1, 2, 3, and 5, while 16 participants are planned for Cohort 4.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants are able to return to the study center for follow-up as required by the protocol and are willing to comply with study policies, procedures, and restrictions; capable of effective communication with the investigator and completing study-related materials; able to understand the contents of the Informed Consent Form (ICF) and sign the written ICF prior to any study procedures.

Healthy Chinese male or female subjects, as determined by medical history and physical examination. At the time of signing the Informed Consent Form (ICF), aged 18-45 years (inclusive) ; body weight ≥ 50 kg for males or ≥ 45 kg for females; and Body Mass Index (BMI) within the range of 19.0-26.0 kg/m² (inclusive).

Participants were considered healthy by the Investigator based on medical history, baseline physical examination, clinical laboratory assessments, and 12-lead ECG, with all results judged as normal or not clinically significant.

Participants of childbearing potential who agree to use effective contraception and have no plans for conception, cryopreservation, or donation of gametes from ICF signature through 3 months after the last dose.

Disqualifiers

Known or suspected hypersensitivity to JMKX003142 (active ingredient or excipients), or a history of hypersensitivity to more than two drugs, foods, or other substances.

History or presence of clinically significant diseases in any of the following systems (including but not limited to): cardiovascular, respiratory, gastrointestinal, hematologic, genitourinary, endocrine/metabolic, nervous, psychiatric, musculoskeletal, dermatologic, lymphatic, immune, or sensory organs; or current active local or systemic infection.

Any condition increasing the risk of bleeding, such as acute gastritis, active ulcer with hemorrhage, clinically significant thrombocytopenia or anemia, active pathological bleeding, or a history of intracranial hemorrhage.

Vital signs meet any of the following criteria at screening: systolic blood pressure ≥ 140 mmHg or < 90 mmHg; diastolic blood pressure ≥ 90 mmHg or < 50 mmHg; pulse rate > 100 bpm or < 50 bpm; or tympanic temperature ≥ 37.5°C or < 35°C.

Trial design

Design model

Parallel

Treatments tested in this trial

  • JMKX003142 tablets

    Drug

    3mg once daily (QD) on Day 1 and Day 7

  • Fluconazole Capsules

    Drug

    400mg QD on Day 4, 200mg QD from Day 5 to Day 9

  • Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets)

    Drug

    Midazolam Oral Solution 2mg, Rosuvastatin Calcium Tablets 5mg and Digoxin Tablets 0.25mg QD on Day 1, Day 8 and Day 21

  • Cyclosporine Soft Capsules

    Drug

    100 mg twice daily (BID) from Day 4 to Day 9

  • Omeprazole Enteric-coated Tablets

    Drug

    40mg QD from Day 4 to Day 8

  • Efavirenz Tablets

    Drug

    600mg QD from Day 4 to Day 12

  • JMKX003142 tablets

    Drug

    6mg QD from Day 8 to Day 25

  • JMKX003142 tablets

    Drug

    6mg QD on Day 1 and Day 8

  • JMKX003142 tablets

    Drug

    6mg QD on Day 1 and Day 10

Treatment groups

112 Participants
are divided into 5 treatment groups
Group A: Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142Experimental treatment 2 interventions
Group B: Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail SubstratesExperimental treatment 2 interventions
Group C: Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142Experimental treatment 2 interventions
Group D: Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142Experimental treatment 2 interventions
Group E: Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites

Time frame
for 120 hours
2

Area Under Curve (AUC) of JMKX003142 and its metabolites

Time frame
for 120 hours
3

Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites

Time frame
for 144 hours
4

Area Under Curve (AUC) of of Midazolam and its metabolites

Time frame
for 144 hours

Secondary outcomes

1

Tmax of JMKX003142 and its metabolites

Time frame
for 120 hours
2

T1/2 of JMKX003142 and its metabolites

Time frame
for 120 hours
3

CL of JMKX003142 and its metabolites

Time frame
for 120 hours
4

Tmax of Midazolam and its metabolites

Time frame
for 144 hours

Other outcomes

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

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