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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_663 |
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This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of MK-1006 will be similar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-1006 80 mg DFC | Experimental | Participants received a single dose of four 20 mg dry filled capsules of MK-1006 |
|
| MK-1006 80 mg FCT | Experimental | Participants received a single dose of two 40 mg film coated tablets of MK-1006 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1006 DFC | Drug | Each dry filled capsule contains 20 mg MK-1006 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 | AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose |
| Maximum Plasma Concentration (Cmax) for MK-1006 | Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Event | Through 30 days post-dose | |
| Number of Participants Who Discontinued Study Medication Due to an Adverse Event | up to 8 days |
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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-1006 DFC, Then MK-1006 FCT | Participants received a single dose of four 20 mg MK-1006 dry filled capsules (DFC) followed by a single dose of two 40 mg MK-1006 film coated tablets (FCT) after a 7 day washout period. |
| FG001 | MK-1006 FCT, Then MK-1006 DFC | Participants received a single dose of two 40 mg film coated tablets (FCT) of MK-1006 followed by a single dose of four 20 mg MK-1006 dry filled capsules (DFC) after a 7 day washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| 7-day Washout Period |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Includes participants who were randomized to receive either a single dose of four 20 mg MK-1006 DFC followed by a single dose of two 40 mg MK-1006 FCT or a single dose of four 20 mg MK-1006 FCT followed by a single dose of two 40 mg MK-1006 DFC |
| 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 | Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 | AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC | Posted | Geometric Mean | 95% Confidence Interval | nM*hr | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose |
|
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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-1006 80 mg FCT | Participants received a single dose of two MK-1006 40 mg film coated tablets |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 |
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| 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 |
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| MK-1006 FCT |
| Drug |
Each film coated tablet contains 40 mg of MK-1006 |
|
| NOT COMPLETED |
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| NOT COMPLETED |
|
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) for MK-1006 | Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC | Posted | Geometric Mean | 95% Confidence Interval | nM | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose |
|
|
|
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| Secondary | Number of Participants Who Experienced at Least One Adverse Event | All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups. | Posted | Number | participants | Through 30 days post-dose |
|
|
|
| Secondary | Number of Participants Who Discontinued Study Medication Due to an Adverse Event | All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups. | Posted | Number | participants | up to 8 days |
|
|
|
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | MK-1006 80 mg DFC | Participants received a single dose of four MK-1006 20 mg dry filled capsules | 0 | 12 | 6 | 12 |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 |
|
| Chest Pain | General disorders | MedDRA 15.0 |
|
| Infusion Site Haematoma | General disorders | MedDRA 15.0 |
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| Infusion Site Inflammation | General disorders | MedDRA 15.0 |
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| Infusion Site Pain | General disorders | MedDRA 15.0 |
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| Vessel Puncture Site Haematoma | General disorders | MedDRA 15.0 |
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| Hypersensitivity | Immune system disorders | MedDRA 15.0 |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 15.0 |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
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| Dizziness | Nervous system disorders | MedDRA 15.0 |
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| Headache | Nervous system disorders | MedDRA 15.0 |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
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 |