Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-1064 · 2 trials · 2 indications
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.
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 study drug, whether or not considered related to the use of 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 study drug, is also an AE.
AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.
| 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. |
| Panel A: MK-1064 5 mg | EXPERIMENTAL | Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. |
| Panel B: MK-1064 10 mg | EXPERIMENTAL | Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. |
| Panel A: MK-1064 25 mg | EXPERIMENTAL | Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. |
| Panel B: MK-1064 50 mg | EXPERIMENTAL | Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. |
| Panel A: MK-1064 100 mg | EXPERIMENTAL | Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. |
| Panel B: MK-1064 150 mg | EXPERIMENTAL | Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. |
| Panel A: MK-1064 200 mg | EXPERIMENTAL | Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. |
| Panel B: MK-1064 250 mg | EXPERIMENTAL | Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. |
| Panel A: MK-1064 25 mg (Fed) | EXPERIMENTAL | In Period 5, participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast. |
| Panel B: MK-1064 50 mg (Night) | EXPERIMENTAL | In Period 5, participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast. |
| Panels A & B: Placebo | PLACEBO_COMPARATOR | Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant. |
| 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 being studied for pharmacokinetics and polysomnography. It is in Phase 1 clinical development by Merck & Company, Inc. (MRK). The drug is not approved and remains under investigation in early-stage trials.
MK-1064 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, pharmacokinetics, and pharmacodynamics.
MK-1064 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy male volunteers aged 18 years and older.
MK-1064 has two completed Phase 1 trials: NCT02549014, a single-dose study of safety, pharmacokinetics, and pharmacodynamics with 16 participants, and NCT02549027, a study evaluating effects on polysomnography with 20 participants. Both were randomized, double-blind, placebo-controlled trials.
No, MK-1064 is not the same as MK-6096. However, a clinical trial (NCT02549027) evaluated the effects of single doses of both MK-1064 and MK-6096 on polysomnography in healthy male volunteers.