Healthy Volunteers
Conditions
Keywords
Mass Balance Recovery, Metabolite Profile, Metabolite Identification
Brief summary
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.
Interventions
DRUG[14C]SJP-0008
Single oral dose of \[14C\]SJP-0008
Sponsors
Quotient Sciences
Senju Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]SJP-0008 | Until the mass balance criteria for all participants have been met (estimated up to Day 10) | Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in plasma, urine and faeces samples. |
Secondary
| Measure | 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) |
Countries
United Kingdom
Outcome results
None listed