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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01110616 | EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010) | PHASE1 | COMPLETED | 25 | — | — | Jun 1, 2010 | Oct 1, 2010 | Nov 2, 2015 | - | — |
| NCT00887601 | BOLD Functional Magnetic Resonance Imaging (fMRI) and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs (3134-006) | PHASE1 | COMPLETED | 32 | — | — | Aug 1, 2007 | May 1, 2008 | Jul 30, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | MK3134-Lorazepam-Placebo-MK3134-Lorazepam |
| Sequence 2 | EXPERIMENTAL | MK3134-Lorazepam-Placebo-Lorazepam-MK3134 |
| Sequence 3 | EXPERIMENTAL | MK3134-Placebo-Lorazepam-MK3134-Lorazepam |
| Sequence 4 | EXPERIMENTAL | MK3134-Placebo-Lorazepam-Lorazepam-MK3134 |
| Sequence 5 | EXPERIMENTAL | Lorazepam-Placebo-MK3134-MK3134-Lorazepam |
| Sequence 6 | EXPERIMENTAL | Lorazepam-Placebo-MK3134-Lorazepam-MK3134 |
| Sequence 7 | EXPERIMENTAL | Lorazepam-MK3134-Placebo-MK3134-Lorazepam |
| Sequence 8 | EXPERIMENTAL | Lorazepam-MK3134-Placebo-Lorazepam-MK3134 |
| Sequence 9 | EXPERIMENTAL | Placebo-MK3134-Lorazepam-MK3134-Lorazepam |
| Sequence 10 | EXPERIMENTAL | Placebo-MK3134-Lorazepam-Lorazepam-MK3134 |
| Sequence 11 | EXPERIMENTAL | Placebo-Lorazepam-MK3134-MK3134-Lorazepam |
| Sequence 12 | EXPERIMENTAL | Placebo-Lorazepam-MK3134-Lorazepam-MK3134 |
| Part I | EXPERIMENTAL | Subjects will receive placebo, MK3134, and donepezil in one of four treatment sequences. |
| Part II | EXPERIMENTAL | Subjects will receive placebo and three different doses of MK3134 (1 mg, 5 mg, and 25 mg) in one of four treatment sequences. |
| Name | Type | Description |
|---|---|---|
| MK3134 | DRUG | MK3134, 25 mg tablets (5 x 5 mg capsule), orally |
| Comparator: Lorazepam | DRUG | Lorazepam, 2 mg (2 x 1 mg tablet), orally |
| Comparator: Placebo | DRUG | Placebo, to match MK3134, and placebo to match Lorazepam |
| Donepezil | DRUG | Single dose 5 mg donepezil capsules in two of the four treatment periods. |
Inclusion Criteria: * Subject is a male between 18 to 40 years of age * The subject has a Body Mass Index (BMI) greater than or equal to 31 kg/m\^2 at the prestudy (screening) visit * Subject has normal or corrected to normal visual and auditory acuity * Subject has been a nonsmoker and/or has not ...