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Completed

NCT Number: NCT04171310

Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 8260001

Nottingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR442168

Drug

Pharmaceutical form:oral solution Route of administration: Oral

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of subjects with Adverse events

    Time frame: From Day -1 to 43

    Adverse events, spontaneously reported by the subject or observed by the Investigator

  2. Blood/plasma radioactivity ratio

    Time frame: Day 1 up to Day 43

    Blood/plasma radioactivity ratio for Cmax

  3. Blood/plasma radioactivity ratio

    Time frame: Day 1 up to Day 43

    Blood/plasma radioactivity ratio for AUC

  4. Plasma SAR442168 /radioactivity ratio

    Time frame: Day 1 up to Day 43

    Plasma SAR442168 /radioactivity ratio for Cmax

  5. Plasma SAR442168 /radioactivity ratio

    Time frame: Day 1 up to Day 43

    Plasma SAR442168 /radioactivity ratio for AUC

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2019
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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