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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2022 |
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Main ID: |
NCT04171310 |
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Date of registration:
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19/11/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects
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Scientific title:
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An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-SAR442168 (Not More Than 3.7 MBq) in Healthy Male Subjects |
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Date of first enrolment:
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November 13, 2019 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04171310 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Clinical Sciences & Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion criteria :
Healthy male subjects 30 to 65 years of age. Body Mass Index 18 up to 32 kg/m2, inclusive.
Signed informed consent. Subjects must agree to the use of an adequate method of
contraception for up to 3 months after discharge from the clinical unit
Exclusion criteria:
Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the
last five years (including diagnostic X-rays and other medical exposures).
Occupationally exposure to radiation (as defined in the Ionizing Radiations Regulations
2017).
Irregular bowel habits (more than 3 bowel movements/day or less than 1 every 2 days) .
Social habits: smoking, alcohol abuse, drug abuse etc.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: SAR442168
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Primary Outcome(s)
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Percentage of radioactive dose excreted in urine and feces
[Time Frame: Day 1 to Day 43]
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Secondary Outcome(s)
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Blood/plasma radioactivity ratio
[Time Frame: Day 1 up to Day 43]
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Number of subjects with Adverse events
[Time Frame: From Day -1 to 43]
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Plasma SAR442168 /radioactivity ratio
[Time Frame: Day 1 up to Day 43]
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Secondary ID(s)
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U1111-1223-4541
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BEX16018
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2019-001069-33
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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