---
title: Single Dose ADME Study of [14C]SJP-0008 in Healthy Male Subjects
nct_id: NCT05320861
overall_status: COMPLETED
phase: PHASE1
sponsor: Senju Pharmaceutical Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05320861.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05320861"
ct_last_update_post_date: 2022-04-11
last_seen_at: "2026-05-12T07:03:26.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05320861](https://clinicaltrials.gov/study/NCT05320861)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 6
- **Lead Sponsor:** Senju Pharmaceutical Co., Ltd.
- **Collaborators:** Quotient Sciences
- **Conditions:** Healthy Volunteers
- **Start Date:** 2021-09-24
- **Completion Date:** 2021-11-02
- **CT.gov Last Update:** 2022-04-11

## 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

- **Minimum age:** 50 Years
- **Maximum age:** 70 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **[14C]SJP-0008** (EXPERIMENTAL)

## Interventions

- **[14C]SJP-0008** (DRUG) — Single oral dose of \[14C\]SJP-0008

## Primary Outcomes

- **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.

## 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))_

## Locations (1)

- Quotient Sciences, Ruddington, Nottingham, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.quotient sciences|ruddington|nottingham|united kingdom` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05320861*  
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