Multiple SclerosisPhase 1NCT04171310
Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects
A Phase 1 study testing SAR442168 in people with Multiple Sclerosis, run by Sanofi at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- SAR442168
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Nov 2019to 30 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- SAR442168
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR442168Drug
Pharmaceutical form:oral solution Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| SAR442168 | Experimental | Single oral dose of SAR442168 (as a nonsalified compound) containing (NMT) 3.7 MBq of [14C]-SAR442168 Receives: Drug: SAR442168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of radioactive dose excreted in urine and feces
Fractional and cumulative percentage of radioactive dose excreted in urine and feces of [14C]-SAR442168
Measured: Day 1 to Day 43
Secondary outcomes (5)
Number of subjects with Adverse events
Adverse events, spontaneously reported by the subject or observed by the Investigator
Measured: From Day -1 to 43
Blood/plasma radioactivity ratio
Blood/plasma radioactivity ratio for Cmax
Measured: Day 1 up to Day 43
Blood/plasma radioactivity ratio
Blood/plasma radioactivity ratio for AUC
Measured: Day 1 up to Day 43
Plasma SAR442168 /radioactivity ratio
Plasma SAR442168 /radioactivity ratio for Cmax
Measured: Day 1 up to Day 43
Plasma SAR442168 /radioactivity ratio
Plasma SAR442168 /radioactivity ratio for AUC
Measured: Day 1 up to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start13 Nov 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171310
- Sponsor's protocol ID
- BEX16018
- Other IDs
- 2019-001069-33, U1111-1223-4541, 2019
- Status last verified
- Sep 2025
- First submitted
- 19 Nov 2019
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04171310
- Acronym / sponsor ID
- BEX16018
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR442168 | Experimental | Drug: SAR442168Single oral dose of SAR442168 (as a nonsalified compound) containing (NMT) 3.7 MBq of [14C]-SAR442168 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR442168Pharmaceutical form:oral solution Route of administration: Oral | Drug | SAR442168 |
Primary outcome
Percentage of radioactive dose excreted in urine and feces
Time frame: Day 1 to Day 43
Fractional and cumulative percentage of radioactive dose excreted in urine and feces of [14C]-SAR442168
5 secondary outcomes
Number of subjects with Adverse events
Time frame: From Day -1 to 43
Blood/plasma radioactivity ratio
Time frame: Day 1 up to Day 43
Blood/plasma radioactivity ratio
Time frame: Day 1 up to Day 43
Plasma SAR442168 /radioactivity ratio
Time frame: Day 1 up to Day 43
Plasma SAR442168 /radioactivity ratio
Time frame: Day 1 up to Day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- BEX16018 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR442168 in people with Multiple Sclerosis, run by Sanofi at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of radioactive dose excreted in urine and feces (time frame: Day 1 to Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.