Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • [14C]JMKX003142

    Drug

    Participants will receive oral \[14C\]JMKX003142

  • JMKX003142 tablets

    Drug

    Participants will receive oral JMKX003142

  • [14C]JMKX003142 solution for infusion

    Drug

    Participants will receive IV \[14C\] JMKX003142

Treatment groups

8 Participants
are divided into 2 treatment groups
Group A: Part1: Mass BalanceExperimental treatment 1 intervention
Group B: Part2: Absolute BioavailabilityExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Mass balance of JMKX003142

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)

Time frame
up to 15 days (until >90% of dose is recovered)
2

Absolute bioavailability of JMKX003142 in plasma

Absolute bioavailability is calculated from the AUCs of iv and oral administration

Time frame
96 hours

Secondary outcomes

1

Part1: Maximum Concentration (Cmax) of JMKX003142 in Plasma

Time frame
Day 1 to day 15 (depending on recovery of dose)
2

Part1: Time to Reach Maximum Concentration (tmax) of JMKX003142 in Plasma

Time frame
Day 1 to day 15 (depending on recovery of dose)
3

Part1: Apparent Terminal Half-Life (t1/2) Of JMKX003142

Time frame
Day 1 to day 15 (depending on recovery of dose)
4

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)

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

This trial is not recruiting at the moment. You can still explore other options: