Healthy
Conditions
Brief summary
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.
Interventions
DRUGMidazolam
Single oral administration of 2 mg midazolam under fasted conditions/outside of meal times
DRUGID-082
Administration of ID-082 under fasted conditions/outside of meal times
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of midazolam | From baseline to EOS (i.e. for up to 16 days) | Maximum plasma concentration |
| AUC0-24 of midazolam | From baseline to EOS (i.e. for up to 16 days) | Area under the plasma concentration-time curvefrom time zero to 24 h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tmax of midazolam and 1-hydroxymidazolam | From baseline to EOS (i.e. for up to 16 days) | Time to reach maximum plasma concentration |
| t½ of midazolam and 1-hydroxymidazolam | From baseline to EOS (i.e. for up to 16 days) | Terminal elimination half-life |
| Cmax of 1-hydroxymidazolam | From baseline to EOS (i.e. for up to 16 days) | Maximum plasma concentration |
| Metabolic ratio (MR) of the AUC0-24 of 1-hydroxymidazolam to the AUC0-24 of midazolam | From baseline to EOS (i.e. for up to 16 days) | — |
| Total body apparent plasma clearance (CL/F) of midazolam | From baseline to EOS (i.e. for up to 16 days) | — |
| AUC0-inf of midazolam and 1-hydroxymidazolam and AUC0-24 of 1-hydroxymidazolam | From baseline to EOS (i.e. for up to 16 days) | Area under the plasma concentration-time curve from zero to infinity |
Countries
United Kingdom
Outcome results
None listed