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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02549014 | A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064 (MK-1064-001) | PHASE1 | COMPLETED | 16 | — | — | Jul 6, 2009 | Sep 29, 2009 | Oct 23, 2018 | - | — |
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.
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 |
|---|---|---|
| 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 | Dose for each period administered as oral MK-1064 tablets (1, 10 and 50 mg strengths) |
| Placebo | DRUG | Dose for each period administered as oral placebo tablets matching active MK-1064 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 approximately 6 months Exclusion Criteria...