Status:
COMPLETED
Single Dose ADME Study of [14C]SJP-0008 in Healthy Male Subjects
Lead Sponsor:
Senju Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Quotient Sciences
Conditions:
Healthy Volunteers
Eligibility:
MALE
50-70 years
Phase:
PHASE1
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 met...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05320861
Start Date
September 24 2021
End Date
November 2 2021
Last Update
April 11 2022
Active Locations (1)
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1
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS