Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01311882 | A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1) | PHASE1 | COMPLETED | 28 | — | — | Apr 1, 2011 | Nov 1, 2011 | Feb 22, 2016 | 1 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| MK-4305 40 mg | EXPERIMENTAL | Day 1 and Day 8- 4 x 10 mg MK-4305 and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 |
| MK-4305 20 mg | EXPERIMENTAL | Day 1 and Day 8- 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo |
| Zopiclone 7.5 mg | ACTIVE_COMPARATOR | Day 1 and Day 8- 1 x 7.5 mg zopiclone and 4 x 10 mg MK-4305 matching placebo; Days 2-7- 4 x 10 mg MK-4305 matching placebo |
| Placebo | PLACEBO_COMPARATOR | Day 1 and Day 8- 4 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 matching placebo |
| Name | Type | Description |
|---|---|---|
| MK-4305 40 mg | DRUG | 4 x 10 mg MK-4305 tablets |
| MK-4305 20 mg | DRUG | 2 x 10 mg MK-4305 tablets |
| Zopiclone | DRUG | 1 x 7.5 mg Zopiclone tablet |
| Grossly Matching Placebo for Zopiclone | DRUG | Grossly Matching Placebo for Zopiclone |
| Matching Placebo for MK-4305 | DRUG | Matching Placebo for MK-4305 |
Inclusion Criteria: * Female participants of reproductive potential must agree to use (and/or have their partner use) acceptable methods of birth control beginning at least 2 weeks prior to the administration of the first dose of study drug throughout the study * Has a body mass index (BMI) within ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 3 | PHASE3 | Tasimelteon |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Suvorexant |
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan , Astra-Zeneca |
| Unity Health Toronto | UBX | 1 | PHASE2 | Lemborexant |
| ResMed Inc. | RMD | 1 | NA | Undisclosed |
| IQVIA Holdings Inc | IQV | 1 | — | Daridorexant, Non-orexin receptor antagonist medications for insomnia |