NCT05320861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

March 23, 2022

Last Update Submit

April 1, 2022

Conditions

Healthy Volunteers

Keywords

Mass Balance RecoveryMetabolite ProfileMetabolite Identification

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

[14C]SJP-0008

EXPERIMENTAL
Drug: [14C]SJP-0008

Interventions

[14C]SJP-0008DRUG

Single oral dose of \[14C\]SJP-0008

[14C]SJP-0008

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

  • Somasekhara Menakuru

    Quotient Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 11, 2022

Study Start

September 24, 2021

Primary Completion

November 2, 2021

Study Completion

November 2, 2021

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)