NCT01954589

Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-462206

Double-blind, Placebo- and Active-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-462206 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A study of ACT-462206 to evaluate the tolerability, safety, pharmacokinetics, and pharmacodynamic of ascending single doses of ACT-462206, a novel dual orexin receptor antagonist in healthy male subjects.

Detailed description

Each dose level will be investigated in a new group of eight healthy male subjects (six on active drug and two on placebo). Each subject will participate in one treatment period, with the exception of subjects in the crossover part (i.e., almorexant reference group at the fourth dose level), who will participate in two treatment periods. At this dose level subjects on active drug (six) will receive in one treatment period ACT-462206 and in the other 400 mg of almorexant; subjects on placebo (two) will receive the corresponding placebos (double-dummy).

Conditions

• Safety
• Tolerability
• Pharmacodynamics
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	ACT-462206 5 mg
DRUG	ACT-462206 25 mg
DRUG	ACT-462206 100mg
DRUG	ACT-462206 200mg
DRUG	ACT-462206 400mg
DRUG	ACT-462206 1000 mg
DRUG	ACT-462206 1500mg
DRUG	Almorexant 400mg
DRUG	Placebo

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2013-10-07
• Last updated: 2018-07-10

Locations

1 site across 1 country: Netherlands