Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects

Idorsia Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ID-082

Drug: Midazolam

Study type

Interventional

Funder types

Industry

Identifiers

NCT03363984

ID-082-102

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.