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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: SAR442168

Study type: Interventional

Funder types: Industry

Identifiers

NCT04171310

BEX16018

2019-001069-33 (EudraCT Number)

U1111-1223-4541 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

SAR442168

Experimental group

Description:

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

Treatment:

Drug: SAR442168