Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam & ID-082 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Single oral administration of 2 mg midazolam under fasted conditions/outside of meal times |
|
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fabienne Le Gac | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec Research Limited | Merthyr Tydfil | Mid Galmorgan | CF48 4DR | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID-082 | Drug | Administration of ID-082 under fasted conditions/outside of meal times |
|
| 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) |
| D006571 | Heterocyclic Compounds |