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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]SJP-0008

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]SJP-0008	Drug: [14C]SJP-0008; Single oral dose of [14C]SJP-0008

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: Senju Pharmaceutical Co., Ltd.
• Collaborators: Quotient Sciences
• Investigators: Principal Investigator: Somasekhara Menakuru, Quotient Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): November 2, 2021

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Mass Balance Recovery; Metabolite Profile; Metabolite Identification
• Other Study ID Numbers: SJP-0008/1-02; 2021-002615-65 (EudraCT Number); 18pc0101026h0001 (Other Grant/Funding Number: The Japan Agency for Medical Research and Development)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No