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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05320861
• Other study ID #: SJP-0008/1-02
• Secondary ID: 2021-002615-6518
• Status: Completed
• Phase: Phase 1
• Start date: September 24, 2021
• Est. completion date: November 2, 2021

Study information

• Verified date: April 2022
• Source: Senju Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]SJP-0008
Single oral dose of [14C]SJP-0008

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Senju Pharmaceutical Co., Ltd.	Quotient Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum plasma concentration (Cmax) of SJP-0008 and SNJ-2026		Up to Day 8
Secondary	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
Secondary	Area under concentration-time curve from time zero to infinity (AUC0-inf) of SJP-0008 and SNJ-2026		Up to Day 8
Secondary	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
Secondary	Time to maximum plasma concentration (Tmax) of SJP-0008 and SNJ-2026		Up to Day 8
Secondary	Half-life (T1/2) of SJP-0008 and SNJ-2026		Up to Day 8
Secondary	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
Secondary	Percentage of participants with adverse events (AEs)		Until the mass balance criteria for all participants have been met (estimated up to Day 10)