Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-1064 · 1 trial · 1 indication
LPS is measured during overnight sleep laboratory (polysomnography \[PSG\]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.
LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.
An 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 preexisting condition which is temporally associated with the use of the study drug, is also an AE.
An 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 preexisting condition which is temporally associated with the use of the study drug, is also an AE.
| Arm | Type | Description |
|---|---|---|
| Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg | EXPERIMENTAL | For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. |
| Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg | EXPERIMENTAL | For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. |
| Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg | EXPERIMENTAL | For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. |
| Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo | EXPERIMENTAL | For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. |
| Name | Type | Description |
|---|---|---|
| MK-1064 | DRUG | Oral MK-1064 tablets (10 and 50 mg strengths) |
| MK-6096 | DRUG | Oral MK-6096 tablets (5 mg strength) |
| Placebo | DRUG | Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets) |
Inclusion Criteria: * Body Mass Index (BMI) ≤31 kg/m\^2 * In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests * Nonsmoker and has not used nicotine or nicotine-containing products for at least 6 months * No history of any sleep disorde...
MK-1064 is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK). It has been studied in a Phase 1 clinical trial evaluating its effects on polysomnography, a sleep monitoring assessment. It is not an approved product and remains in clinical development.
MK-1064 has been studied for effects on polysomnography, the sleep monitoring technique used to record brain waves, eye movements, and muscle activity during sleep. The single Phase 1 trial enrolled healthy male volunteers aged 18 years and older. No approved use has been established for MK-1064.
MK-1064 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 1 study of the compound. The drug remains an investigational asset in the company's clinical pipeline.
MK-1064 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study was randomized, double-blind, and controlled, with 20 participants enrolled. MK-1064 is investigational and has not been approved for any indication.
MK-1064 has been evaluated in one completed Phase 1 trial, NCT02549027, titled a study to evaluate the effects of single doses of MK-1064 and MK-6096 on polysomnography. The trial enrolled 20 healthy male volunteers aged 18 years and older and used a randomized, double-blind, controlled design.