Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects

A Single-center, Open-label Study to Investigate the Effect of a Single Oral Dose and Repeated Oral Doses of ID-082 on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Male Subjects.

A clinical study in healthy male subjects to investigate whether the administration of ID-082 can affect the fate in the body (amount and time of presence in the blood) of midazolam.

Inclusion Criteria:

• Signed informed consent in the local language prior to any study-mandated procedure;
• Healthy male subjects aged 18 to 45 years (inclusive) at screening;
• Male subject with a female partner of childbearing potential or a pregnant partner must agree to use a condom from screening, during the study, and for at least 3 months after last study treatment intake;
• Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at screening;
• Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion Criteria:

• Contraindication or known hypersensitivity to ID-082, midazolam or drugs of the same classes, or any of their excipients;
• Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy;
• History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment;
• Known hypersensitivity or allergy to natural rubber latex;
• Known hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency;
• Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions;
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.