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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_652 | Other Identifier | Merck Registration ID | |
| MK-0941-009 | Other Identifier | Merck Protocol ID |
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A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) & oral compressed tablet (OCT) formulations of MK-0941-009 & to assess the effect of food on the OCT formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFC (fasted) | Experimental |
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| OCT (fasted) | Experimental |
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| OCT (after meal) | Experimental |
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| OCT (before meal) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 mg MK-0941 DFC (fasted) | Drug | single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted) | From study drug administration to 72 hours post-administration | |
| Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted) | From study drug administration to 72 hours post-administration | |
| Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted) | From study drug administration to 72 hours post-administration | |
| Half Life (t½) for OCT (Fasted) and DFC (Fasted) | From study drug administration to 72 hours post-administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-∞) for OCT (Fasted) and OCT (After Meal) | From study drug administration to 72 hours post-administration | |
| Cmax of OCT (Fasted) and OCT (After Meal) | From study drug administration to 72 hours post-administration |
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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 | Treatment Group ABCD |
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| FG001 | Treatment Group BACD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 (3 Days) |
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| 10 mg MK-0941 OCT (after meal) | Drug | single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal |
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| 10 mg MK-0941 OCT (before meal) | Drug | single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast |
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| 10 mg MK-0941 OCT (fasted) | Drug | single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state |
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| Tmax for OCT (Fasted) and OCT (After Meal) | From study drug administration to 72 hours post-administration |
| t1/2 for OCT (Fasted) and OCT (After Meal) | From study drug administration to 72 hours post-administration |
| FG002 | Treatment Group BCD |
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| COMPLETED |
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| NOT COMPLETED |
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| Washout Period 1 (3 Days) |
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| Treatment Period 2 (3 Days) |
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| Washout Period 2 (3 Days) |
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| Treatment Period 3 (3 Days) |
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| Washout Period 3 (3 Days) |
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| Treatment Period 4 (3 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized | Includes the 15 participants who were randomized and started the study in Treatment Period 1 (Baseline) and the 3 additional participants who were subsequently randomized and started the study in Treatment Period 2. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted) | Participants with AUC(0-∞) measurements | Posted | Least Squares Mean | Full Range | nM*hr | From study drug administration to 72 hours post-administration |
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| Primary | Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted) | Participants with Cmax measurements | Posted | Least Squares Mean | Full Range | nM | From study drug administration to 72 hours post-administration |
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| Secondary | AUC(0-∞) for OCT (Fasted) and OCT (After Meal) | Participants with AUC(0-∞) measurements | Posted | Least Squares Mean | Full Range | nM*hr | From study drug administration to 72 hours post-administration |
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| Secondary | Cmax of OCT (Fasted) and OCT (After Meal) | Participants with Cmax measurements | Posted | Least Squares Mean | Full Range | nM | From study drug administration to 72 hours post-administration |
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| Primary | Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted) | Participants with Tmax measurements | Posted | Median | Full Range | hours | From study drug administration to 72 hours post-administration |
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| Primary | Half Life (t½) for OCT (Fasted) and DFC (Fasted) | Participants with t1/2 measurements | Posted | Median | Full Range | hours | From study drug administration to 72 hours post-administration |
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| Secondary | Tmax for OCT (Fasted) and OCT (After Meal) | Participants with Tmax measurements | Posted | Median | Full Range | hours | From study drug administration to 72 hours post-administration |
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| Secondary | t1/2 for OCT (Fasted) and OCT (After Meal) | Participants with t1/2 measurements | Posted | Median | Full Range | hours | From study drug administration to 72 hours post-administration |
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From first dose of study drug administration through to 72 hours post-administration
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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 | OCT (Fasted) | Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state | 0 | 18 | 6 | 18 | ||
| EG001 | OCT (After Meal) | Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal | 0 | 17 | 7 | 17 | ||
| EG002 | OCT (Before Meal) | Participants receiving a single dose of 10 mg MK-0941 OCT administered before consumption of a standard breakfast | 0 | 14 | 3 | 14 | ||
| EG003 | DFC (Fasted) | Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state | 0 | 15 | 4 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Infusion site erythema | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Tongue Blistering | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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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.
| 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 |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019518 | Postprandial Period |
| ID | Term |
|---|---|
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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