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| ID | Type | Description | Link |
|---|---|---|---|
| 174001 | Other Identifier | Organon Protocol Number |
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Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.
This is a randomized, placebo-controlled, safety and tolerability study examining MK-8777 in participants with major depressive disorder. In Part I of the trial, four different cohorts of six participants each will receive multiple rising doses of MK-8777 (ranging from 100 mg twice a day [BID] to 300 mg BID) or placebo for up to 16 days. In Part 2, a new cohort of participants will be randomly assigned to receive 100 mg BID of MK-8777, 400 mg BID of MK-8777, or placebo. Following titration (3 days per step), participants will be maintained on the assigned BID dose until Day 27, followed by one day of once a day (QD) dosing, for a total of 28 days. There were 11 treatment arms in total for Part 1 and Part 2 (see Interventions).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Block A MK-8777 | Experimental | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days. |
|
| Part 1: Block A Placebo | Placebo Comparator | Participants receive placebo BID for a total of 16 days. |
|
| Part 1: Block B MK-8777 | Experimental | Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days. |
|
| Part 1: Block B Placebo | Placebo Comparator | Participants receive placebo BID for a total of 13 days. |
|
| Part 1: Block C MK-8777 | Experimental | Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. |
|
| Part 1: Block C Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8777 | Drug | Orally administered capsules containing either 50 mg or 100 mg MK-8777. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) | 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 product. A moderate intensity AE is defined as an AE that causes no significant interference with functioning. | Up to 7 days following the last dose of study drug (Up to 23 days) |
| Part 1: Number of Participants With Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. | Up to 30 days following the last dose of study drug (Up to 46 days) |
| Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug | 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 product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo). | Up to the last dose of study drug (Up to 16 days) |
| Part 2: Number of Participants With AEs | 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 product. | Up to 7 days following the last dose of study drug (Up to 35 days) |
| Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34510411 | Derived | Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3. | |
| 22954616 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Block A MK-8777 | Participants receive MK-8777 initiated at 100 mg twice daily (BID) and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days. |
| FG001 | Part 1: Block A Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Comparator |
Participants receive placebo BID for a total of 10 days. |
|
| Part 1: Block D MK-8777 | Experimental | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. |
|
| Part 1: Block D Placebo | Placebo Comparator | Participants receive placebo BID for a total of 13 days. |
|
| Part 2: MK-8777 200 mg | Experimental | Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days. |
|
| Part 2: MK-8777 800 mg | Experimental | Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days. |
|
| Part 2: Placebo | Placebo Comparator | Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days. |
|
| Placebo | Drug | Orally administered matching placebo capsules. |
|
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 product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).
| Up to the last dose of study drug (Up to 28 days) |
| Baseline and end of treatment (Up to Day 16) |
| Part 2: Change From Baseline in the MADRS | The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression. | Baseline and end of treatment (Up to Day 28) |
| Nations KR, Dogterom P, Bursi R, Schipper J, Greenwald S, Zraket D, Gertsik L, Johnstone J, Lee A, Pande Y, Ruigt G, Ereshefsky L. Examination of Org 26576, an AMPA receptor positive allosteric modulator, in patients diagnosed with major depressive disorder: an exploratory, randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2012 Dec;26(12):1525-39. doi: 10.1177/0269881112458728. Epub 2012 Sep 6. |
Participants receive placebo BID for a total of 16 days.
| FG002 | Part 1: Block B MK-8777 | Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days. |
| FG003 | Part 1: Block B Placebo | Participants receive placebo BID for a total of 13 days. |
| FG004 | Part 1: Block C MK-8777 | Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. |
| FG005 | Part 1: Block C Placebo | Participants receive placebo BID for a total of 10 days. |
| FG006 | Part 1: Block D MK-8777 | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. |
| FG007 | Part 1: Block D Placebo | Participants receive placebo BID for a total of 13 days. |
| FG008 | Part 2: MK-8777 200 mg | Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg once daily (QD). Participants receive MK-8777 for a total of 28 days. |
| FG009 | Part 2: MK-8777 800 mg | Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days. |
| FG010 | Part 2: Placebo | Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Block A MK-8777 | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days. |
| BG001 | Part 1: Block A Placebo | Participants receive placebo BID for a total of 16 days. |
| BG002 | Part 1: Block B MK-8777 | Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days. |
| BG003 | Part 1: Block B Placebo | Participants receive placebo BID for a total of 13 days. |
| BG004 | Part 1: Block C MK-8777 | Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. |
| BG005 | Part 1: Block C Placebo | Participants receive placebo BID for a total of 10 days. |
| BG006 | Part 1: Block D MK-8777 | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. |
| BG007 | Part 1: Block D Placebo | Participants receive placebo BID for a total of 13 days. |
| BG008 | Part 2: MK-8777 200 mg | Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days. |
| BG009 | Part 2: MK-8777 800 mg | Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days. |
| BG010 | Part 2: Placebo | Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days. |
| BG011 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) | 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 product. A moderate intensity AE is defined as an AE that causes no significant interference with functioning. | The All Subjects Treated (AST) population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo). | Posted | Number | participants | Up to 7 days following the last dose of study drug (Up to 23 days) |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. | The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo). | Posted | Number | participants | Up to 30 days following the last dose of study drug (Up to 46 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug | 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 product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo). | The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo). | Posted | Number | participants | Up to the last dose of study drug (Up to 16 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Number of Participants With AEs | 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 product. | The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo). | Posted | Number | participants | Up to 7 days following the last dose of study drug (Up to 35 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug | 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 product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo). | The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo). | Posted | Number | participants | Up to the last dose of study drug (Up to 28 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression. | The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo). | Posted | Mean | Standard Deviation | score on a scale | Baseline and end of treatment (Up to Day 16) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in the MADRS | The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression. | The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo). | Posted | Mean | Standard Deviation | score on a scale | Baseline and end of treatment (Up to Day 28) |
|
Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Block A MK-8777 | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days. | 0 | 4 | 4 | 4 | ||
| EG001 | Part 1: Block A Placebo | Participants receive placebo BID for a total of 16 days. | 0 | 2 | 2 | 2 | ||
| EG002 | Part 1: Block B MK-8777 | Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days. | 0 | 4 | 4 | 4 | ||
| EG003 | Part 1: Block B Placebo | Participants receive placebo BID for a total of 13 days. | 0 | 2 | 2 | 2 | ||
| EG004 | Part 1: Block C MK-8777 | Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. | 0 | 4 | 4 | 4 | ||
| EG005 | Part 1: Block C Placebo | Participants receive placebo BID for a total of 10 days. | 0 | 2 | 1 | 2 | ||
| EG006 | Part 1: Block D MK-8777 | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. | 0 | 4 | 4 | 4 | ||
| EG007 | Part 1: Block D Placebo | Participants receive placebo BID for a total of 13 days. | 0 | 2 | 2 | 2 | ||
| EG008 | Part 2: MK-8777 200 mg | Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days. | 0 | 10 | 10 | 10 | ||
| EG009 | Part 2: MK-8777 800 mg | Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days. | 0 | 10 | 9 | 10 | ||
| EG010 | Part 2: Placebo | Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days. | 0 | 10 | 9 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Colour blindness | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Altered visual depth perception | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Reflux gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Feeling drunk | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bradykinesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bradyphrenia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Depersonalisation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Euphoric mood | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Phonophobia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tension | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
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 |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| Male |
|
| Part 1: Block B Placebo |
Participants receive placebo BID for a total of 13 days. |
| OG004 | Part 1: Block C MK-8777 | Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. |
| OG005 | Part 1: Block C Placebo | Participants receive placebo BID for a total of 10 days. |
| OG006 | Part 1: Block D MK-8777 | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. |
| OG007 | Part 1: Block D Placebo | Participants receive placebo BID for a total of 13 days. |
|
|
| Part 1: Block B Placebo |
Participants receive placebo BID for a total of 13 days. |
| OG004 | Part 1: Block C MK-8777 | Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. |
| OG005 | Part 1: Block C Placebo | Participants receive placebo BID for a total of 10 days. |
| OG006 | Part 1: Block D MK-8777 | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. |
| OG007 | Part 1: Block D Placebo | Participants receive placebo BID for a total of 13 days. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Part 1: Block B Placebo | Participants receive placebo BID for a total of 13 days. |
| OG004 | Part 1: Block C MK-8777 | Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. |
| OG005 | Part 1: Block C Placebo | Participants receive placebo BID for a total of 10 days. |
| OG006 | Part 1: Block D MK-8777 | Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. |
| OG007 | Part 1: Block D Placebo | Participants receive placebo BID for a total of 13 days. |
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Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
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