Diabetes Mellitus, Non-Insulin-Dependent
Conditions
Brief summary
A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in Japanese participants with T2DM.
Interventions
DRUGMK-1006
MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C.
DRUGPlacebo
Matching placebo to MK-1006 in a single oral dose
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Japanese male or female between 20 to 64 years of age * Diagnosis of type 2 diabetes * Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent
Exclusion criteria
* Subject has a history of type 1 diabetes mellitus * Subject has a clinical diagnosis of glaucoma * Subject has donated blood or participated in another clinical study in the past 12 weeks * Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Event | from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days) | An adverse event 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 product. |
| Number of Participants Who Discontinued Treatment Due to an Adverse Event | up to approximately 17 days | An adverse event 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 product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose) | The placebo group was not evaluated for this outcome measure. |
| Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose) | The placebo group was not evaluated for this outcome measure. |
| Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 | Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose) | AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure. |
| 24-hour Weighted Mean Glucose (WMG) Concentration | Up to 36 hours | Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24. |
| Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 | Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose) | The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure. |
| Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 | Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose) | AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Panel A: MK-1006 15/30/45 Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. | 8 |
| Panel B: MK-1006 60/80/60 Fed Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. | 8 |
| Panel C: MK-1006 100/140/170 Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. | 8 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 7 Day Wash-out | Abnormal Clinical Laboratory Test | 0 | 0 | 1 |
| 7 Day Wash-out | Adverse Event | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Panel A: MK-1006 15/30/45 | Panel B: MK-1006 60/80/60 Fed | Panel C: MK-1006 100/140/170 | Total |
|---|---|---|---|---|
| Age, Customized <41 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >= 41 years and <=64 years | 8 Participants | 8 Participants | 8 Participants | 24 Participants |
| Age, Customized >64 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 8 participants | 8 participants | 8 participants | 24 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 8 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 6 | 1 / 6 | 0 / 6 | 1 / 6 | 1 / 6 | 3 / 6 | 1 / 6 | 1 / 4 | 1 / 5 | 1 / 15 | 1 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 4 | 0 / 5 | 0 / 15 | 0 / 2 |
Outcome results
Primary
Number of Participants Who Discontinued Treatment Due to an Adverse Event
An adverse event 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 product.
Time frame: up to approximately 17 days
Population: Participants who received study drug. The same participant may appear in more than one treatment arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1006 15 mg | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 participants |
| MK-1006 30 mg | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 participants |
| MK-1006 45 mg | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 participants |
| MK-1006 60 mg | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 participants |
| MK-1006 60 mg Fed | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 participants |
| MK-1006 80 mg | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 participants |
| MK-1006 100 mg | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 1 participants |
| MK-1006 140 mg | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 participants |
| MK-1006 170 mg | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 participants |
| Placebo | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 participants |
| Placebo Fed | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 participants |
Primary
Number of Participants Who Experienced at Least One Adverse Event
An adverse event 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 product.
Time frame: from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)
Population: Participants who received study drug. The same participant may appear in more than one treatment arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1006 15 mg | Number of Participants Who Experienced at Least One Adverse Event | 1 participants |
| MK-1006 30 mg | Number of Participants Who Experienced at Least One Adverse Event | 1 participants |
| MK-1006 45 mg | Number of Participants Who Experienced at Least One Adverse Event | 0 participants |
| MK-1006 60 mg | Number of Participants Who Experienced at Least One Adverse Event | 1 participants |
| MK-1006 60 mg Fed | Number of Participants Who Experienced at Least One Adverse Event | 1 participants |
| MK-1006 80 mg | Number of Participants Who Experienced at Least One Adverse Event | 3 participants |
| MK-1006 100 mg | Number of Participants Who Experienced at Least One Adverse Event | 0 participants |
| MK-1006 140 mg | Number of Participants Who Experienced at Least One Adverse Event | 1 participants |
| MK-1006 170 mg | Number of Participants Who Experienced at Least One Adverse Event | 1 participants |
| Placebo | Number of Participants Who Experienced at Least One Adverse Event | 1 participants |
| Placebo Fed | Number of Participants Who Experienced at Least One Adverse Event | 1 participants |
Secondary
24-hour Weighted Mean Glucose (WMG) Concentration
Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.
Time frame: Up to 36 hours
Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| MK-1006 15 mg | 24-hour Weighted Mean Glucose (WMG) Concentration | 206.2 mg/dL | 95% Confidence Interval 50.8 |
| MK-1006 30 mg | 24-hour Weighted Mean Glucose (WMG) Concentration | 197.6 mg/dL | 95% Confidence Interval 40.9 |
| MK-1006 45 mg | 24-hour Weighted Mean Glucose (WMG) Concentration | 188.6 mg/dL | 95% Confidence Interval 28 |
| MK-1006 60 mg | 24-hour Weighted Mean Glucose (WMG) Concentration | 178.0 mg/dL | 95% Confidence Interval 24.7 |
| MK-1006 60 mg Fed | 24-hour Weighted Mean Glucose (WMG) Concentration | 165.7 mg/dL | 95% Confidence Interval 26.7 |
| MK-1006 80 mg | 24-hour Weighted Mean Glucose (WMG) Concentration | 156.7 mg/dL | 95% Confidence Interval 21.7 |
| MK-1006 100 mg | 24-hour Weighted Mean Glucose (WMG) Concentration | 199.0 mg/dL | 95% Confidence Interval 33.6 |
| MK-1006 140 mg | 24-hour Weighted Mean Glucose (WMG) Concentration | 170.4 mg/dL | 95% Confidence Interval 25.8 |
| MK-1006 170 mg | 24-hour Weighted Mean Glucose (WMG) Concentration | 154.9 mg/dL | 95% Confidence Interval 21.4 |
| Placebo | 24-hour Weighted Mean Glucose (WMG) Concentration | 214.3 mg/dL | 95% Confidence Interval 34.5 |
| Placebo Fed | 24-hour Weighted Mean Glucose (WMG) Concentration | 185.4 mg/dL | 95% Confidence Interval 17.7 |
Comparison: At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.p-value: 0.36890% CI: [-23, 6.8]Mixed Models Analysis
Comparison: At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.p-value: 0.07990% CI: [-32.2, -1.1]Mixed Models Analysis
Comparison: At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.p-value: 0.00790% CI: [-40.9, -10.5]Mixed Models Analysis
Comparison: At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.p-value: <0.00190% CI: [-52, -20.5]Mixed Models Analysis
p-value: 0.14790% CI: [-42.2, 2.7]Mixed Models Analysis
p-value: 0.11490% CI: [-0.5, 25.2]Mixed Models Analysis
p-value: 0.02690% CI: [-49.9, -7.9]Mixed Models Analysis
Comparison: At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.p-value: <0.00190% CI: [-73.3, -41.9]Mixed Models Analysis
Comparison: At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.p-value: 0.09990% CI: [-30.5, -0.1]Mixed Models Analysis
Comparison: At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.p-value: <0.00190% CI: [-60.8, -27]Mixed Models Analysis
Comparison: At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.p-value: <0.00190% CI: [-75.1, -43.7]Mixed Models Analysis
Secondary
Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006
The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.
Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-1006 15 mg | Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 | 18.0 hours | Standard Deviation 5.5 |
| MK-1006 30 mg | Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 | 18.5 hours | Standard Deviation 3.8 |
| MK-1006 45 mg | Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 | 19.1 hours | Standard Deviation 2.2 |
| MK-1006 60 mg | Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 | 18.5 hours | Standard Deviation 3.5 |
| MK-1006 60 mg Fed | Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 | 17.0 hours | Standard Deviation 1.7 |
| MK-1006 80 mg | Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 | 21.2 hours | Standard Deviation 2.9 |
| MK-1006 100 mg | Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 | 22.1 hours | Standard Deviation 5.2 |
| MK-1006 140 mg | Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 | 20.7 hours | Standard Deviation 2.6 |
| MK-1006 170 mg | Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 | 21.5 hours | Standard Deviation 4 |
Secondary
Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006
AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.
Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-1006 15 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 | 358 nM*hr | Standard Deviation 116 |
| MK-1006 30 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 | 665 nM*hr | Standard Deviation 186 |
| MK-1006 45 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 | 1450 nM*hr | Standard Deviation 315 |
| MK-1006 60 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 | 1720 nM*hr | Standard Deviation 782 |
| MK-1006 60 mg Fed | Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 | 1440 nM*hr | Standard Deviation 342 |
| MK-1006 80 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 | 2790 nM*hr | Standard Deviation 1000 |
| MK-1006 100 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 | 4610 nM*hr | Standard Deviation 1730 |
| MK-1006 140 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 | 5370 nM*hr | Standard Deviation 1330 |
| MK-1006 170 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 | 7540 nM*hr | Standard Deviation 3010 |
Secondary
Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006
AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.
Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-1006 15 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 | 489 nM*hr | Standard Deviation 134 |
| MK-1006 30 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 | 904 nM*hr | Standard Deviation 249 |
| MK-1006 45 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 | 1900 nM*hr | Standard Deviation 384 |
| MK-1006 60 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 | 2350 nM*hr | Standard Deviation 897 |
| MK-1006 60 mg Fed | Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 | 2100 nM*hr | Standard Deviation 556 |
| MK-1006 80 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 | 3820 nM*hr | Standard Deviation 1300 |
| MK-1006 100 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 | 6060 nM*hr | Standard Deviation 2180 |
| MK-1006 140 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 | 6920 nM*hr | Standard Deviation 1420 |
| MK-1006 170 mg | Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 | 9560 nM*hr | Standard Deviation 3490 |
Mixed-effect model
Secondary
Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006
The placebo group was not evaluated for this outcome measure.
Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-1006 15 mg | Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | 37.3 nM | Standard Deviation 16.3 |
| MK-1006 30 mg | Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | 75.4 nM | Standard Deviation 23.9 |
| MK-1006 45 mg | Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | 169 nM | Standard Deviation 49.8 |
| MK-1006 60 mg | Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | 185 nM | Standard Deviation 102 |
| MK-1006 60 mg Fed | Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | 141 nM | Standard Deviation 41 |
| MK-1006 80 mg | Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | 310 nM | Standard Deviation 172 |
| MK-1006 100 mg | Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | 514 nM | Standard Deviation 180 |
| MK-1006 140 mg | Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | 628 nM | Standard Deviation 205 |
| MK-1006 170 mg | Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | 912 nM | Standard Deviation 371 |
Mixed-effect model
Secondary
Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006
The placebo group was not evaluated for this outcome measure.
Time frame: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MK-1006 15 mg | Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | 3.0 hours |
| MK-1006 30 mg | Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | 4.0 hours |
| MK-1006 45 mg | Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | 3.0 hours |
| MK-1006 60 mg | Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | 4.0 hours |
| MK-1006 60 mg Fed | Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | 5.0 hours |
| MK-1006 80 mg | Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | 4.0 hours |
| MK-1006 100 mg | Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | 3.5 hours |
| MK-1006 140 mg | Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | 5.0 hours |
| MK-1006 170 mg | Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | 3.0 hours |