Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h).

Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Theranexus
• Collaborator: Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
• Treatments: Armodafinil; Modafinil

Criteria

Main inclusion Criteria:

1. Male subjects considered healthy and aged between 18 and 40 years

2. Subject with a body mass index (BMI) between 18 and 30 kg/m2