Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects

NCT04171310 | Completed Phase 1

• 3 other identifiers: BEX160182019-001069-33U1111-1223-4541
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Percentage of radioactive dose excreted in urine and feces

  Fractional and cumulative percentage of radioactive dose excreted in urine and feces of \[14C\]-SAR442168

  Day 1 to Day 43

Secondary Outcomes (5)

• Number of subjects with Adverse events

  From Day -1 to 43

• Blood/plasma radioactivity ratio

  Day 1 up to Day 43

• Blood/plasma radioactivity ratio

  Day 1 up to Day 43

• Plasma SAR442168 /radioactivity ratio

  Day 1 up to Day 43

• Plasma SAR442168 /radioactivity ratio

  Day 1 up to Day 43

Study Arms (1)

SAR442168

EXPERIMENTAL

Single oral dose of SAR442168 (as a nonsalified compound) containing (NMT) 3.7 MBq of \[14C\]-SAR442168

Drug: SAR442168

Interventions

SAR442168 DRUG

Pharmaceutical form:oral solution Route of administration: Oral

SAR442168

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 8260001

Nottingham, United Kingdom

Location

Related Links

• BEX16018 Plain Language Results Summary

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 20, 2019
• Study Start: November 13, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)