Clinical trial NCT05320861: Single Dose ADME Study of [14C]SJP-0008 in Healthy Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Mass Balance Recovery
Metabolite Profile
Metabolite Identification
Lead sponsor: Senju Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Quotient Sciences
First posted: 2022-04-11
Enrollment: 6
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]SJP-0008
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to Day 10)
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) of SJP-0008 and SNJ-2026
timeFrame: Up to Day 8
measure: Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last) of SJP-0008 and SNJ-2026
timeFrame: Up to Day 8
measure: Area under concentration-time curve from time zero to infinity (AUC0-inf) of SJP-0008 and SNJ-2026
timeFrame: Up to Day 8
measure: 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
timeFrame: Up to Day 8
measure: Time to maximum plasma concentration (Tmax) of SJP-0008 and SNJ-2026
timeFrame: Up to Day 8
measure: Half-life (T1/2) of SJP-0008 and SNJ-2026
timeFrame: Up to Day 8
measure: First order rate constant associated with the terminal (log-linear) portion of the curve (Lambda-z) of SJP-0008 and SNJ-2026
timeFrame: Up to Day 8
measure: Percentage of participants with adverse events (AEs)
timeFrame: Until the mass balance criteria for all participants have been met (estimated up to Day 10)
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
affiliation: Quotient Sciences
name: Somasekhara Menakuru
role: PRINCIPAL_INVESTIGATOR
References: