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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01092780 | Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010) | PHASE1 | COMPLETED | 56 | — | — | May 26, 2010 | May 31, 2011 | Nov 8, 2018 | - | — |
Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.
Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.
| Arm | Type | Description |
|---|---|---|
| MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil | EXPERIMENTAL | Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
| MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo | EXPERIMENTAL | Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
| Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg | EXPERIMENTAL | Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
| Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg | EXPERIMENTAL | Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. |
| Name | Type | Description |
|---|---|---|
| MK-7288 | DRUG | one or two 10 mg capsules, orally, single dose |
| Placebo to MK-7288 | DRUG | one or two capsules, orally, single dose |
| Modafinil | DRUG | two 100 mg tablets, orally, single dose |
| Placebo to modafinil | DRUG | two 100 mg tablets, orally, single dose |
Inclusion Criteria: * Female participants are of non-child-bearing potential. * Male participants who have female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study. * Participant has an International Classification of Sleep Disor...