NCT03681158

Study of Excretion Balance and Pharmacokinetics of [14C]-Sodium Valproate (3.7 MBq) in Healthy Postmenopausal or Permanently Sterile Female Subjects

An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-Sodium Valproate (3.7 MBq) in Healthy Postmenopausal or Permanently Sterile Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Primary Objectives: * To determine the excretion balance and systemic exposure of radioactivity after oral administration of \[14C\]-sodium valproate (VPA) . * To determine the pharmacokinetics of sodium VPA and metabolite(s) and its contribution to the overall exposure of radioactivity. * To collect samples in order to determine the metabolic pathways of sodium VPA and identify the chemical structures and main excretion route of the main metabolites. Secondary Objective: To assess the clinical and biological tolerability of oral solution of sodium VPA.

Detailed description

Total study duration is 3 to 10 weeks, including a screening period of 8 to 28 days, treatment period of up to 15 days and a follow-up and end of study of up to 4 weeks.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	sodium valproate	Pharmaceutical form:Powder for oral solution reconstituted with water Route of administration: Oral

Timeline

• Start date: 2018-10-05
• Primary completion: 2019-04-11
• Completion: 2019-04-11
• First posted: 2018-09-21
• Last updated: 2022-04-25

Locations

1 site across 1 country: United Kingdom