Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5186582 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| IV Midazolam Alone | OTHER | A single 1 milligram (mg) dose of IV Midazolam on Day 1. |
| Oral Midazolam Alone | OTHER | A single 5 mg oral dose of midazolam on Day 2. |
| RO5186582 Alone | EXPERIMENTAL | RO5186582 240 mg oral tablet twice daily (BID) for 14 days from Days 3 to 16. |
| RO5186582 Plus IV Midazolam | EXPERIMENTAL | RO5186582 240 mg BID oral tablet in combination with a single 1 mg IV dose of midazolam on Day 17. |
| RO5186582 Plus Oral Midazolam | EXPERIMENTAL | RO5186582 240 mg BID in combination with a single 5 mg oral dose of midazolam on Day 18. |
| Name | Type | Description |
|---|---|---|
| Midazolam, IV | DRUG | 2 milligrams per milliliter (mg/mL) midazolam solution for IV administration. For a 1 mg dose, the midazolam solution (0.5 mL of 2 mg/mL) will be injected at 2 milligrams per minute (mg/min). |
| Midazolam, oral | DRUG | 0.1 mg/mL midazolam for oral administration. For a 5 mg dose, participants will receive 50 mL of 0.1 mg/mL midazolam. |
| RO5186582 | DRUG | RO5186582 120 mg film-coated release tablet. |
Inclusion Criteria: * Healthy participants with signed informed consent. Exclusion Criteria: * A history of epilepsy, convulsions or significant head injury * Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of th...
RO5186582 is an investigational small molecule being studied in healthy volunteers. It was evaluated in a Phase 1 clinical trial to assess its effect on cytochrome P450 (CYP) 3A4 activity. The drug is not approved for any indication and remains in clinical development.
RO5186582 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company sponsored a Phase 1 study of the drug in healthy participants in the United Kingdom.
RO5186582 is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently listed for the drug. It is investigational and has not been approved by regulatory authorities.
RO5186582 was studied in one completed Phase 1 trial, NCT02254759, titled "A Study of RO5186582 Treatment on Cytochrome P450 (CYP) 3A4 Activity in Healthy Participants." The trial enrolled 12 healthy adults in the United Kingdom and was controlled but not randomized or double-blinded.
RO5186582 is a small molecule that was studied for its effect on cytochrome P450 (CYP) 3A4 activity. The Phase 1 trial measured how the drug influences this enzyme, which is involved in drug metabolism. Its precise mechanism of action is not fully described in available data.
RO5186582 is not FDA approved. It is an investigational drug that has completed a Phase 1 trial in healthy volunteers. The drug is still in clinical development, and no approval status has been established.