Mass Balance and Absolute Bioavailability Study of JMKX003142 In Healthy Volunteers

ConditionADPKD (Autosomal Dominant Polycystic Kidney Disease)

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexMale

Age18-45

SponsorJemincare

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

[14C]JMKX003142
JMKX003142 tablets
[14C]JMKX003142 solution for infusion

Treatment groups

8 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Jemincare

Lead sponsor

Zhejiang Hangyu Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov