Back to resultsStudy of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
SAR442168
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
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.
Sites / Locations
- Investigational Site Number 8260001
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SAR442168
Arm Description
Single oral dose of SAR442168 (as a nonsalified compound) containing (NMT) 3.7 MBq of [14C]-SAR442168
Outcomes
Primary Outcome Measures
Percentage of radioactive dose excreted in urine and feces
Fractional and cumulative percentage of radioactive dose excreted in urine and feces of [14C]-SAR442168
Secondary Outcome Measures
Number of subjects with Adverse events
Adverse events, spontaneously reported by the subject or observed by the Investigator
Blood/plasma radioactivity ratio
Blood/plasma radioactivity ratio for Cmax
Blood/plasma radioactivity ratio
Blood/plasma radioactivity ratio for AUC
Plasma SAR442168 /radioactivity ratio
Plasma SAR442168 /radioactivity ratio for Cmax
Plasma SAR442168 /radioactivity ratio
Plasma SAR442168 /radioactivity ratio for AUC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04171310
Brief Title
Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective:
To determine the excretion balance and systemic exposure of radioactivity after oral administration of [14C]-SAR442168.
To determine the pharmacokinetics of SAR442168 and its contribution to the overall exposure of radioactivity.
To collect samples in order to determine the metabolic pathways of SAR442168 and identify the chemical structures and main excretion route of the main metabolites (samples will be analyzed according to metabolic analysis plan and results will be documented in a separate report).
Secondary Objective:
To assess the clinical and biological tolerability of an oral solution of SAR442168.
Detailed Description
Total study duration is 3 to 10 weeks, including a screening period of 27 days, treatment period of up to 15 days and a follow-up and end of study of up to 4 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAR442168
Arm Type
Experimental
Arm Description
Single oral dose of SAR442168 (as a nonsalified compound) containing (NMT) 3.7 MBq of [14C]-SAR442168
Intervention Type
Drug
Intervention Name(s)
SAR442168
Intervention Description
Pharmaceutical form:oral solution Route of administration: Oral
Primary Outcome Measure Information:
Title
Percentage of radioactive dose excreted in urine and feces
Description
Fractional and cumulative percentage of radioactive dose excreted in urine and feces of [14C]-SAR442168
Time Frame
Day 1 to Day 43
Secondary Outcome Measure Information:
Title
Number of subjects with Adverse events
Description
Adverse events, spontaneously reported by the subject or observed by the Investigator
Time Frame
From Day -1 to 43
Title
Blood/plasma radioactivity ratio
Description
Blood/plasma radioactivity ratio for Cmax
Time Frame
Day 1 up to Day 43
Title
Blood/plasma radioactivity ratio
Description
Blood/plasma radioactivity ratio for AUC
Time Frame
Day 1 up to Day 43
Title
Plasma SAR442168 /radioactivity ratio
Description
Plasma SAR442168 /radioactivity ratio for Cmax
Time Frame
Day 1 up to Day 43
Title
Plasma SAR442168 /radioactivity ratio
Description
Plasma SAR442168 /radioactivity ratio for AUC
Time Frame
Day 1 up to Day 43
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 8260001
City
Nottingham
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects
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