Single Dose ADME Study of [14C]SJP-0008 in Healthy Male Subjects

Study Overview
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Brief Summary
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This single centre, open-label, non-randomised, single period, single-dose study in healthy male subjects was designed and conducted to assess the mass balance recovery, PK, metabolite profile and metabolite identification of SJP-0008.

Official Title
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A Single Dose Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]SJP-0008 in Healthy Male Subjects After an Oral Dose

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C]SJP-0008


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening Must be willing and able to communicate and participate in the whole study Must have regular bowel movements Must provide written informed consent Must agree to adhere to the contraception requirements of the protocol Exclusion Criteria: Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1 Subjects who are, or are immediate family members of, a study site or sponsor employee Subjects who report to have previously received SJP-0008 Evidence of current SARS-CoV-2 infection History of any drug or alcohol abuse in the past 2 years Regular alcohol consumption in males >21 units per week A confirmed positive alcohol breath test at screening or admission Current smokers and those who have smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months Subjects with pregnant or lactating partners Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]SJP-0008<br> | Drug: [14C]SJP-0008<br>* Single oral dose of [14C]SJP-0008<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]SJP-0008 | Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in plasma, urine and faeces samples. | Until the mass balance criteria for all participants have been met (estimated up to Day 10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of SJP-0008 and SNJ-2026 |  | Up to Day 8 | 
| Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last) of SJP-0008 and SNJ-2026 |  | Up to Day 8 | 
| Area under concentration-time curve from time zero to infinity (AUC0-inf) of SJP-0008 and SNJ-2026 |  | Up to Day 8 | 
| Area under the concentration-time curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) of SJP-0008 and SNJ-2026 |  | Up to Day 8 | 
| Time to maximum plasma concentration (Tmax) of SJP-0008 and SNJ-2026 |  | Up to Day 8 | 
| Half-life (T1/2) of SJP-0008 and SNJ-2026 |  | Up to Day 8 | 
| First order rate constant associated with the terminal (log-linear) portion of the curve (Lambda-z) of SJP-0008 and SNJ-2026 |  | Up to Day 8 | 
| Percentage of participants with adverse events (AEs) |  | Until the mass balance criteria for all participants have been met (estimated up to Day 10) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mass Balance Recovery, Metabolite Profile, Metabolite Identification