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Not yet recruiting NCT07463053

Mass Balance and Absolute Bioavailability Study of JMKX003142 In Healthy Volunteers

Phase I Interventional ADPKD (Autosomal Dominant Polycystic Kidney Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [14C]JMKX003142, JMKX003142 tablets, [14C]JMKX003142 solution for infusion.
Who it may be relevant to
Registry conditions: ADPKD (Autosomal Dominant Polycystic Kidney Disease). Basic parameters: 18 years — 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Study to Evaluate the Mass Balance and Absolute Bioavailability of [14C]JMKX003142 in Healthy Male Participants

Overview

A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral JMKX003142. The study will be conducted in two parts: Part 1 to assess the mass balance of JMKX003142 using orally administered radiolabelled JMKX003142; part 2 will assess the absolute bioavailability using JMKX003142 and radiolabelled JMKX003142 as intravenous and oral forms

Interventions

  • Drug [14C]JMKX003142
    Participants will receive oral \[14C\]JMKX003142
  • Drug JMKX003142 tablets
    Participants will receive oral JMKX003142
  • Drug [14C]JMKX003142 solution for infusion
    Participants will receive IV \[14C\] JMKX003142

Primary outcome measures

  • Mass balance of JMKX003142 [Time frame: up to 15 days (until >90% of dose is recovered)]
  • Absolute bioavailability of JMKX003142 in plasma [Time frame: 96 hours]
Secondary outcome measures (5)
  • Part1: Maximum Concentration (Cmax) of JMKX003142 in Plasma [Time frame: Day 1 to day 15 (depending on recovery of dose)]
  • Part1: Time to Reach Maximum Concentration (tmax) of JMKX003142 in Plasma [Time frame: Day 1 to day 15 (depending on recovery of dose)]
  • Part1: Apparent Terminal Half-Life (t1/2) Of JMKX003142 [Time frame: Day 1 to day 15 (depending on recovery of dose)]
  • Part1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of JMKX003142 in Plasma [Time frame: Day 1 to day 15 (depending on recovery of dose)]
  • Frequency and severity of Participants With Adverse Events (AEs) [Time frame: Up to Day 30]

Eligibility criteria

Inclusion criteria

  • Chinese healthy males.
  • The age between 18 and 45 years (extremes included), on the date of signing the informed consent form (ICF).
  • Body mass index (BMI) range of 19-26.0 kg/m² (inclusive of boundary values), with body weight not less than 55.0 kg.

Exclusion criteria

  • Abnormal findings with clinical significance on comprehensive physical examination, vital signs, digital rectal examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis, fecal routine with occult blood, thyroid function), ophthalmological examination, 12-lead electrocardiogram, chest X-ray (posteroanterior view), and abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys).
  • White blood cell count and/or hemoglobin below the lower limit of the normal range in complete blood count.
  • Resting corrected QT interval (QTcF) >450 ms (corrected by Fridericia's formula, QTcF = QT/RR\^1/3).
  • Hepatitis B surface antigen or E antigen positive, anti-HCV IgG positive, syphilis treponemal antibody positive, and HIV antigen/antibody combination test positive.
  • Subjects with gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or those with a history of severe vomiting or diarrhea within one week prior to screening.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07463053 · JMKX003142-105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗