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

Launched by SENJU PHARMACEUTICAL CO., LTD. · Apr 1, 2022

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• 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