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This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy volunteers.
A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be co-administered on Day 15, after an overnight fast.
Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bitopertin-Midazolam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Single oral doses will be given on Days 1 and 15, after an overnight fast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration | Days 1 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration | Days 1 and 15 | |
| Incidence of adverse events | Approximately 76 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| C550631 | (4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanone |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| bitopertin | Drug | An oral dose will be given daily in the morning from Days 2-15. On Days 14 and 15, bitopertin will be given after an overnight fast; on Days 2-13, bitopertin will be given under fed conditions. |
|
| D006571 | Heterocyclic Compounds |