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A Phase 1, open-label, single-center study to determine the absorption, distribution, metabolism, and excretion of a single oral dose of SAR443820 containing microtracer [14C]-SAR443820 in healthy male participants

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502534-23-00
Acronym
BEX17501
Enrollment
6
Registered
2023-05-02
Start date
2023-06-02
Completion date
2023-07-17
Last updated
2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

amyotrophic lateral sclerosis (ALS)

Brief summary

Primary endpoint: Pharmacokinetics Pharmacokinetic data will be summarized using descriptive statistics for each appropriate matrix. The results of other primary endpoint analyses of plasma and excreta samples collected to determine the metabolic pathways of SAR443820 and identify the chemical structures and main excretion routes of the main metabolites will be documented separately.

Detailed description

Safety analysis (adverse events [AEs], laboratory parameters, vital signs, and electrocardiograms [ECGs]) will be based on the review of individual values and descriptive statistics.

Interventions

Sponsors

Sanofi-Aventis Research & Development
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Pharmacokinetics Pharmacokinetic data will be summarized using descriptive statistics for each appropriate matrix. The results of other primary endpoint analyses of plasma and excreta samples collected to determine the metabolic pathways of SAR443820 and identify the chemical structures and main excretion routes of the main metabolites will be documented separately.

Secondary

MeasureTime frame
Safety analysis (adverse events [AEs], laboratory parameters, vital signs, and electrocardiograms [ECGs]) will be based on the review of individual values and descriptive statistics.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026