ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Conditions
Brief summary
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
Participants will receive oral JMKX003142
DRUG[14C]JMKX003142 solution for infusion
Participants will receive IV \[14C\] JMKX003142
Sponsors
Jemincare
Zhejiang Hangyu Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Chinese healthy males. 2. The age between 18 and 45 years (extremes included), on the date of signing the informed consent form (ICF). 3. 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
1. 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). 2. White blood cell count and/or hemoglobin below the lower limit of the normal range in complete blood count. 3. Resting corrected QT interval (QTcF) \>450 ms (corrected by Fridericia's formula, QTcF = QT/RR\^1/3). 4. Hepatitis B surface antigen or E antigen positive, anti-HCV IgG positive, syphilis treponemal antibody positive, and HIV antigen/antibody combination test positive. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mass balance of JMKX003142 | up to 15 days (until >90% of dose is recovered) | Total recovery of radioactivity in urine and faeces following a single oral dose of \[14C\]-JMKX003142 (expressed as a percentage of the total radioactive dose administered) |
| Absolute bioavailability of JMKX003142 in plasma | 96 hours | Absolute bioavailability is calculated from the AUCs of iv and oral administration |
Secondary
| Measure | Time frame |
|---|---|
| Part1: Maximum Concentration (Cmax) of JMKX003142 in Plasma | Day 1 to day 15 (depending on recovery of dose) |
| Part1: Time to Reach Maximum Concentration (tmax) of JMKX003142 in Plasma | Day 1 to day 15 (depending on recovery of dose) |
| Part1: Apparent Terminal Half-Life (t1/2) Of JMKX003142 | 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 | Day 1 to day 15 (depending on recovery of dose) |
| Frequency and severity of Participants With Adverse Events (AEs) | Up to Day 30 |
Outcome results
None listed