Investigation of the effect of the dual orexin receptor antagonist almorexant on ophthalmological, spermatogenic, and hormonal variables in healthy male subjects

• Published in: Biomedicine & pharmacotherapy Vol. 133; p. 110955
• Main Authors: Dingemanse, Jasper, Charef, Pascal, Black, Jed, Gouws, Chris
• Format: Journal Article
• Language: English
• Published: France Elsevier Masson SAS 01.01.2021
• Subjects: Acetamides - administration & dosage; Acetamides - adverse effects; Acetamides - blood; Acetamides - pharmacokinetics; Administration, Oral; Adult; Almorexant; Biomarkers - blood; Double-Blind Method; Drug Administration Schedule; Healthy Volunteers; Hormones; Hormones - blood; Humans; Isoquinolines - administration & dosage; Isoquinolines - adverse effects; Isoquinolines - blood; Isoquinolines - pharmacokinetics; Lacrimal Apparatus - drug effects; Lacrimal Apparatus - physiology; Male; Meibomian gland; Ophthalmology; Orexin; Orexin Receptor Antagonists - administration & dosage; Orexin Receptor Antagonists - adverse effects; Orexin Receptor Antagonists - blood; Orexin Receptor Antagonists - pharmacokinetics; Patient Safety; Prospective Studies; Risk Assessment; Sleep Aids, Pharmaceutical - administration & dosage; Sleep Aids, Pharmaceutical - adverse effects; Sleep Aids, Pharmaceutical - blood; Sleep Aids, Pharmaceutical - pharmacokinetics; South Africa; Spermatogenesis; Spermatogenesis - drug effects; Tears; Time Factors; Young Adult; South Africa; Hormones; Ophthalmology; Spermatogenesis; Meibomian gland; Orexin; Almorexant

•The dual orexin receptor antagonist almorexant was administered once daily to healthy male subjects for 4 weeks.•A battery of ophthalmological, spermatogenetic, and hormone variables was assessed.•No clinically relevant effects were detected in spite of some findings in toxicology studies in rats a...