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| Name | Class |
|---|---|
| Zhejiang Hangyu Pharmaceutical Co., Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1: Mass Balance | Experimental | Participants will receive oral [14C] JMKX003142 under fasted conditions |
|
| Part2: Absolute Bioavailability | Experimental | Participants will receive oral JMKX003142 under fasted conditions, followed by intravenous IV [14C] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]JMKX003142 | Drug | Participants will receive oral [14C]JMKX003142 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 15 days (until >90% of dose is recovered) |
| Absolute bioavailability of JMKX003142 in plasma | Absolute bioavailability is calculated from the AUCs of iv and oral administration | 96 hours |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| JMKX003142 tablets |
| Drug |
Participants will receive oral JMKX003142 |
|
| [14C]JMKX003142 solution for infusion | Drug | Participants will receive IV [14C] JMKX003142 |
|
| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |