Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008_584 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: MK-1006 15/30/45 | Experimental | Participants received a single rising 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. |
|
| Panel B: MK-1006 60/80/60 fed | Experimental | Participants received a single rising 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. |
|
| Panel C: MK-1006 100/140/170 | Experimental | Participants received a single rising 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1006 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| 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. | up to approximately 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||||||||
| 7 Day Wash-out |
| |||||||||||||||||||
| Period 2 |
| |||||||||||||||||||
| 7 Day Wash-out |
| |||||||||||||||||||
| Period 3 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who received study drug. The same participant may appear in more than one treatment arm. | Posted | Number | participants | 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) |
|
Not provided
The same participant may appear in more than one treatment arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-1006 15 mg | Participants received a single dose of MK-1006 15 mg |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 11.0 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo to MK-1006 in a single oral dose |
|
| 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. | 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) |
| Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | The placebo group was not evaluated for this outcome measure. | 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) |
| Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 | The placebo group was not evaluated for this outcome measure. | 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) |
| 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. | 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) |
| 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. | Up to 36 hours |
| NOT COMPLETED |
|
|
| Received Matching Placebo to MK-1006 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Received Matching Placebo to MK-1006 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants received a single dose of MK-1006 30 mg
| OG002 | MK-1006 45 mg | Participants received a single dose of MK-1006 45 mg |
| OG003 | MK-1006 60 mg | Participants received a single dose of MK-1006 60 mg |
| OG004 | MK-1006 60 mg Fed | Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast |
| OG005 | MK-1006 80 mg | Participants received a single dose of MK-1006 80 mg |
| OG006 | MK-1006 100 mg | Participants received a single dose of MK-1006 100 mg |
| OG007 | MK-1006 140 mg | Participants received a single dose of MK-1006 140 mg |
| OG008 | MK-1006 170 mg | Participants received a single dose of MK-1006 170 mg |
| OG009 | Placebo | Participants received matching placebo to MK-1006 |
| OG010 | Placebo Fed | Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | nM*hr | 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) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | nM*hr | 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) |
|
|
|
| Secondary | Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 | The placebo group was not evaluated for this outcome measure. | 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. | Posted | Mean | Standard Deviation | nM | 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) |
|
|
|
|
| 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. | 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. | Posted | Median | Full Range | hours | 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) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | hours | 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) |
|
|
|
| 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. | Participants who received study drug. The same participant may appear in more than one treatment arm. | Posted | Number | participants | up to approximately 17 days |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Up to 36 hours |
|
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | MK-1006 30 mg | Participants received a single dose of MK-1006 30 mg | 0 | 6 | 1 | 6 |
| EG002 | MK-1006 45 mg | Participants received a single dose of MK-1006 45 mg | 0 | 6 | 0 | 6 |
| EG003 | MK-1006 60 mg | Participants received a single dose of MK-1006 60 mg | 0 | 6 | 1 | 6 |
| EG004 | MK-1006 60 mg Fed | Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast | 0 | 6 | 1 | 6 |
| EG005 | MK-1006 80 mg | Participants received a single dose of MK-1006 80 mg | 0 | 6 | 3 | 6 |
| EG006 | MK-1006 100 mg | Participants received a single dose of MK-1006 100 mg | 0 | 6 | 1 | 6 |
| EG007 | MK-1006 140 mg | Participants received a single dose of MK-1006 140 mg | 0 | 4 | 1 | 4 |
| EG008 | MK-1006 170 mg | Participants received a single dose of MK-1006 170 mg | 0 | 5 | 1 | 5 |
| EG009 | Placebo | Participants received matching placebo to MK-1006 | 0 | 15 | 1 | 15 |
| EG010 | Placebo Fed | Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast | 0 | 2 | 1 | 2 |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 11.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 11.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 |
|
| Headache | Nervous system disorders | MedDRA 11.0 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 |
|
| Blood triglycerides increased | Investigations | MedDRA 11.0 |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D004700 | Endocrine System Diseases |
| No |
| Superiority or Other |
| 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. | Mixed Models Analysis | Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect. | 0.079 | A step down procedure starting with the highest tolerated dose was implemented. | Difference in least squares mean | -16.6 | 2-Sided | 90 | -32.2 | -1.1 | The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 30 mg minus LS mean for placebo. | No | Superiority or Other |
| 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. | Mixed Models Analysis | Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect. | 0.007 | A step down procedure starting with the highest tolerated dose was implemented. | Difference in least squares mean | -25.7 | 2-Sided | 90 | -40.9 | -10.5 | The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 45 mg minus LS mean for placebo. | No | Superiority or Other |
| 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. | Mixed Models Analysis | Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect. | <.001 | A step down procedure starting with the highest tolerated dose was implemented. | Diffrence in least squares mean | -36.3 | 2-Sided | 90 | -52.0 | -20.5 | The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg minus LS mean for placebo. | No | Superiority or Other |
| Mixed Models Analysis | Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect. | 0.147 | Difference in least squares mean | -19.7 | 2-Sided | 90 | -42.2 | 2.7 | The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg fed minus LS mean for placebo fed. | No | Superiority or Other |
| Mixed Models Analysis | Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect. | 0.114 | Difference in least squares mean | 12.3 | 2-Sided | 90 | -0.5 | 25.2 | Difference in least squares mean (LS mean) was calculated as LS mean for MK-1006 60 mg minus LS mean for MK-1006 60 mg fed. | No | Superiority or Other |
| Mixed Models Analysis | Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect. | 0.026 | Difference in least squares mean | -28.9 | 2-Sided | 90 | -49.9 | -7.9 | The calculation used to determine the difference in least squares mean (LS mean) was LS mean for placebo fed minus LS mean for placebo. | No | Superiority or Other |
| 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. | Mixed Models Analysis | Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect. | <.001 | A step down procedure starting with the highest tolerated dose was implemented. | Difference in least squares mean | -57.6 | 2-Sided | 90 | -73.3 | -41.9 | The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 80 mg minus LS mean for placebo. | No | Superiority or Other |
| 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. | Mixed Models Analysis | Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect. | 0.099 | A step down procedure starting with the highest tolerated dose was implemented. | Difference in least squares mean | -15.3 | 2-Sided | 90 | -30.5 | -0.1 | The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 100 mg minus LS mean for placebo. | No | Superiority or Other |
| 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. | Mixed Models Analysis | Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect. | <.001 | A step down procedure starting with the highest tolerated dose was implemented. | Difference in least squares mean | -43.9 | 2-Sided | 90 | -60.8 | -27.0 | The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 140 mg minus LS mean for placebo. | No | Superiority or Other |
| 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. | Mixed Models Analysis | Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect. | <.001 | A step down procedure starting with the highest tolerated dose was implemented. | Difference in least squares mean | -59.4 | 2-Sided | 90 | -75.1 | -43.7 | The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 170 mg minus LS mean for placebo. | No | Superiority or Other |