Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Midazolam
* Drug: ID-082


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam & ID-082<br>Single oral administration of 2 mg midazolam on Day 1, Day 2, and Day 11. Administration of ID-082 from Day 2 through Day 11. | Drug: Midazolam<br>* Single oral administration of 2 mg midazolam under fasted conditions/outside of meal times<br>Drug: ID-082<br>* Administration of ID-082 under fasted conditions/outside of meal times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of midazolam | Maximum plasma concentration | From baseline to EOS (i.e. for up to 16 days) | 
| AUC0-24 of midazolam | Area under the plasma concentration-time curvefrom time zero to 24 h | From baseline to EOS (i.e. for up to 16 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of 1-hydroxymidazolam | Maximum plasma concentration | From baseline to EOS (i.e. for up to 16 days) | 
| AUC0-inf of midazolam and 1-hydroxymidazolam and AUC0-24 of 1-hydroxymidazolam | Area under the plasma concentration-time curve from zero to infinity | From baseline to EOS (i.e. for up to 16 days) | 
| tmax of midazolam and 1-hydroxymidazolam | Time to reach maximum plasma concentration | From baseline to EOS (i.e. for up to 16 days) | 
| t½ of midazolam and 1-hydroxymidazolam | Terminal elimination half-life | 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) | 
| 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) |