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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171310
• Other study ID #: BEX16018
• Secondary ID: 2019-001069-33U1
• Status: Completed
• Phase: Phase 1
• Start date: November 13, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• SAR442168
Pharmaceutical form:oral solution Route of administration: Oral

Locations

Country	Name	City	State
United Kingdom	Investigational Site Number 8260001	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of subjects with Adverse events	Adverse events, spontaneously reported by the subject or observed by the Investigator	From Day -1 to 43
Secondary	Blood/plasma radioactivity ratio	Blood/plasma radioactivity ratio for Cmax	Day 1 up to Day 43
Secondary	Blood/plasma radioactivity ratio	Blood/plasma radioactivity ratio for AUC	Day 1 up to Day 43
Secondary	Plasma SAR442168 /radioactivity ratio	Plasma SAR442168 /radioactivity ratio for Cmax	Day 1 up to Day 43
Secondary	Plasma SAR442168 /radioactivity ratio	Plasma SAR442168 /radioactivity ratio for AUC	Day 1 up to Day 43