Healthy VolunteersPhase 1NCT05320861
Single Dose ADME Study of [14C]SJP-0008 in Healthy Male Subjects
A Phase 1 study testing [14C]SJP-0008 in people with Healthy Volunteers, run by Senju Pharmaceutical Co., Ltd. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]SJP-0008
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2021to 2 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]SJP-0008
- Keywords
- Mass Balance Recovery, Metabolite Profile, Metabolite Identification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]SJP-0008Drug
Single oral dose of [14C]SJP-0008
| Study group | Role | What they receive |
|---|---|---|
| [14C]SJP-0008 | Experimental | Not described Receives: Drug: [14C]SJP-0008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Up to Day 8
Area under concentration-time curve from time zero to infinity (AUC0-inf) of SJP-0008 and SNJ-2026
Measured: 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
Measured: Up to Day 8
Time to maximum plasma concentration (Tmax) of SJP-0008 and SNJ-2026
Measured: Up to Day 8
Half-life (T1/2) of SJP-0008 and SNJ-2026
Measured: 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
Measured: Up to Day 8
Percentage of participants with adverse events (AEs)
Measured: Until the mass balance criteria for all participants have been met (estimated up to Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start24 Sep 2021
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senju Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Somasekhara Menakuru, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320861
- Sponsor's protocol ID
- SJP-0008/1-02
- Other IDs
- 2021-002615-65, 18pc0101026h0001
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05320861
- Acronym / sponsor ID
- SJP-0008/1-02
- Conditions
- Healthy Volunteers
- Keywords
- Mass Balance Recovery, Metabolite Profile, Metabolite Identification
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Senju Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]SJP-0008 | Experimental | Drug: [14C]SJP-0008 |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]SJP-0008Single oral dose of [14C]SJP-0008 | Drug | [14C]SJP-0008 |
Primary outcome
Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]SJP-0008
Time frame: 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.
8 secondary outcomes
Maximum plasma concentration (Cmax) of SJP-0008 and SNJ-2026
Time frame: 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
Time frame: Up to Day 8
Area under concentration-time curve from time zero to infinity (AUC0-inf) of SJP-0008 and SNJ-2026
Time frame: 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
Time frame: Up to Day 8
Time to maximum plasma concentration (Tmax) of SJP-0008 and SNJ-2026
Time frame: Up to Day 8
Half-life (T1/2) of SJP-0008 and SNJ-2026
Time frame: 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
Time frame: Up to Day 8
Percentage of participants with adverse events (AEs)
Time frame: Until the mass balance criteria for all participants have been met (estimated up to Day 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somasekhara Menakuru principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]SJP-0008 in people with Healthy Volunteers, run by Senju Pharmaceutical Co., Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]SJP-0008 (time frame: Until the mass balance criteria for all participants have been met (estimated up to Day 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.