NCT03400189

Pharmacokinetics and Tolerability of Sulthiame

Preliminary Pilot Exploration of the Pharmacokinetic and Tolerability Profile of Sulthiame in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This preliminary pilot exploration aims at specifying the pharmacokinetic parameters of sulthiame, formulated as an immediate release tablet, thus helping to design proper clinical trials for the future assessment of new paediatric formulations currently under development. The clinical tolerability to single doses of sulthiame will also be closely monitored to orient future trials.

Detailed description

Sulthiame (or sultiame), marketed in the 60's in Germany, Austria, Switzerland, Israel, Australia and Japan under the brand name Ospolot®, has progressively become the therapeutic first choice in benign focal epilepsies of childhood in these countries. Its antiepileptic activity is thought to result from the inhibition of various subtypes of carbonic anhydrase (hCA), in particular cytosolic hCA II, thus inducing a degree of intracellular acidification sufficient to stabilize seizure-eliciting neurons. The pharmacokinetic profile of sulthiame was scarcely studied in humans. Sulthiame is a suitable candidate for paediatric formulation optimization, as the current formulation (coated tablets of 50 or 200 mg) allows neither precise and adapted dosing, nor convenient administration to young children.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Sulthiame	Single dose (50, 100, 200 mg)

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-05-22
• Completion: 2018-08-30
• First posted: 2018-01-17
• Last updated: 2020-02-18

Locations

1 site across 1 country: Switzerland