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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_526 | Other Identifier | Merck Telerex ID Number | |
| MK-0941-027 | Other Identifier | protocol number |
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This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg |
|
| Treatment Sequence 2 | Experimental | Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo |
|
| Treatment Sequence 3 | Experimental | Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg |
|
| Treatment Sequence 4 | Experimental | Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0941 | Drug | A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced One or More Adverse Events During the Study | Up to 30 days after the last dose of study drug | |
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Only treatment-emergent adverse events were examined for this outcome measure. | Up to 6 weeks after the first dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-0941 60/80/100/120 mg/Pbo | Treatment Sequence 1 |
| FG001 | MK-0941 60/80 mg/Pbo/MK-0941 120/140 mg | Treatment Sequence 2 |
| FG002 | MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg | Treatment Sequence 3 |
| FG003 | Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg | Treatment Sequence 4 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-0941 60/80/100/120 mg/Pbo | Treatment Sequence 1 |
| BG001 | MK-0941 60/80/Pbo/ MK-0941 120/140 mg | Treatment Sequence 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 One or More Adverse Events During the Study | All participants receiving any dose of MK-0941 or placebo | Posted | Number | participants | Up to 30 days after the last dose of study drug |
|
Up to 30 days after the last dose of study drug
The 13 study participants received multiple doses of drug at different dose levels.
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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 | MK-0941 60 mg | All participants receiving at least one dose of 60 mg of MK-0941 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C569222 | 3-((6-(ethylsulfonyl)-3-pyridinyl)oxy)-5-(2-hydroxy-1-methylethoxy)-N-(1-methyl-1H-pyrazol-3-yl)benzamide |
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| Comparator: Placebo | Drug | a single oral placebo will be administered in the designated period (Periods 1-5) |
|
| BG002 | MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg | Treatment Sequence 3 |
| BG003 | Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg | Treatment Sequence 4 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 | MK-0941 120 mg | All participants receiving a 120-mg dose of MK-0941 |
| OG004 | MK-0941 140 mg | All participants receiving a 140-mg dose of MK-0941 |
| OG005 | Placebo | All participants receiving placebo |
|
|
| Primary | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Only treatment-emergent adverse events were examined for this outcome measure. | All participants receiving any dose of MK-0941 of placebo. | Posted | Number | participants | Up to 6 weeks after the first dose of study drug |
|
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | MK-0941 80 mg | All participants receiving at least one dose of 80 mg of MK-0941 | 0 | 9 | 6 | 9 |
| EG002 | MK-0941 100 mg | All participants receiving at least one dose of 100 mg of MK-0941 | 0 | 9 | 4 | 9 |
| EG003 | MK-0941 120 mg | All participants receiving at least one dose of 120 mg of MK-0941 | 0 | 9 | 9 | 9 |
| EG004 | MK-0941 140 mg | All participants receiving at least one dose of 140 mg of MK-0941 | 0 | 9 | 4 | 9 |
| EG005 | Placebo | All participants receiving placebo | 0 | 13 | 4 | 13 |
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Application site irritation | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Puncture site pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Temperature intolerance | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Cellulitus | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
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. Sponsor review can be expedited to meet publication guidelines.
| D004700 | Endocrine System Diseases |