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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_549 |
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This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed) | Experimental | Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5. |
|
| Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed) | Experimental | Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
|
| 15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed) | Experimental | Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
|
| 15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed) | Experimental | Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK1006 | Drug | MK1006 capsules: 1 mg, 10 mg, and 20 mg. Panel A: MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: MK1006 capsules in five doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) On Study | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience. | 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 3 weeks) |
| Number of Participants Who Discontinued Treatment Due to an AE | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience. | 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 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006 | The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. | From pre-dose to 168 hours post-dose |
| Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose |
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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 | 15mg MK1006/Placebo/45mg MK1006/60mg MK1006/Placebo (Fed) | Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5. |
| FG001 | Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed) | Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
| FG002 | 15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed) | Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
| FG003 | 15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed) | Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5. |
| FG004 | 60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo | Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. |
| FG005 | Placebo/80mg MK1006/100mg MK1006/120mg MK1006/140mg MK1006 | Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. |
| FG006 | 60mg MK1006/80mg MK1006/Placebo/120mg MK1006/140mg MK1006 | Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. |
| FG007 | 60 mg MK1006/80 mg MK1006/100 mg MK1006/Placebo/140 mg MK1006 | Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. |
| FG008 | 140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo | Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5 |
| FG009 | Placebo/170mg MK1006/200mg MK1006/230mg MK1006/260mg MK1006 | Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. |
| FG010 | 140mg MK1006/170mg MK1006/Placebo/230mg MK1006/260mg MK1006 | Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. |
| FG011 | 140mg MK1006/170mg MK1006/200mg MK1006/Placebo/260mg MK1006 | Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| Period 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants were treated with MK1006 or dose-matched placebo over 5 treatment periods. |
| 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 Experiencing Adverse Events (AEs) On Study | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience. | All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug. | 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 3 weeks) |
|
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 3 weeks)
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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 | 15 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 15.0 |
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 |
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| 60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo | Experimental | Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. |
|
| Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006 | Experimental | Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5 |
|
| 60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006 | Experimental | Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. |
|
| 60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006 | Experimental | Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5. |
|
| 140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo | Experimental | Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5. |
|
| Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006 | Experimental | Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. |
|
| 140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006 | Experimental | Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5 |
|
| 140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006 | Experimental | Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5. |
|
|
| Placebo | Drug | Placebo capsule to match MK1006 1, 10, and 20 mg. Panel A: Placebo to MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: Placebo to MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: Placebo to MK1006 capsules in 5 doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose |
|
| From pre-dose to 168 hours post-dose |
| Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose | From pre-dose to 168 hours post-dose |
| Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose | The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination | From pre-dose to 168 hours post-dose |
| Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006 | The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. | From pre-dose to 168 hours post-dose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 30 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast |
| OG002 | 45 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast. |
| OG003 | 60 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast. |
| OG004 | 80 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast. |
| OG005 | 100 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast. |
| OG006 | 120 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast. |
| OG007 | 140 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast. |
| OG008 | 170 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast. |
| OG009 | 200 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast. |
| OG010 | 230 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast. |
| OG011 | 260 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast. |
| OG012 | 30 mg MK1006 [Fed State] | After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast. |
| OG013 | Placebo | After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006. |
|
|
| Secondary | Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006 | The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. | Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations. | Posted | Mean | Standard Deviation | nM.hr | From pre-dose to 168 hours post-dose |
|
|
|
|
| Secondary | Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose | Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations. | Posted | Mean | Standard Deviation | nM | From pre-dose to 168 hours post-dose |
|
|
|
|
| Secondary | Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose | Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations. | Posted | Median | Full Range | hr | From pre-dose to 168 hours post-dose |
|
|
|
| Secondary | Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose | The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination | Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations. | Posted | Mean | Standard Deviation | hr | From pre-dose to 168 hours post-dose |
|
|
|
| Primary | Number of Participants Who Discontinued Treatment Due to an AE | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience. | All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug. | 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 3 weeks) |
|
|
|
| Secondary | Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006 | The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. | Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations. | Posted | Mean | Standard Deviation | nM.hr | From pre-dose to 168 hours post-dose |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | 30 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast | 0 | 6 | 3 | 6 |
| EG002 | 45 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast. | 0 | 6 | 3 | 6 |
| EG003 | 60 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast. | 0 | 12 | 2 | 12 |
| EG004 | 80 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast. | 0 | 6 | 2 | 6 |
| EG005 | 100 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast. | 0 | 6 | 1 | 6 |
| EG006 | 120 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast. | 0 | 6 | 1 | 6 |
| EG007 | 140 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast. | 0 | 12 | 5 | 12 |
| EG008 | 170 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast. | 0 | 6 | 1 | 6 |
| EG009 | 200 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast. | 0 | 6 | 3 | 6 |
| EG010 | 230 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast. | 0 | 6 | 2 | 6 |
| EG011 | 260 mg MK1006 | After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast. | 0 | 4 | 3 | 4 |
| EG012 | 30 mg MK1006 [Fed State] | After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast. | 0 | 6 | 2 | 6 |
| EG013 | Placebo | After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006. | 0 | 24 | 12 | 24 |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 15.0 |
|
| Vertigo Positional | Ear and labyrinth disorders | MedDRA 15.0 |
|
| Conjunctival Hyperaemia | Eye disorders | MedDRA 15.0 |
|
| Dry Eye | Eye disorders | MedDRA 15.0 |
|
| Eye Pruritus | Eye disorders | MedDRA 15.0 |
|
| Ocular Hyperaemia | Eye disorders | MedDRA 15.0 |
|
| Pterygium | Eye disorders | MedDRA 15.0 |
|
| Vision Blurred | Eye disorders | MedDRA 15.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 |
|
| Asthenia | General disorders | MedDRA 15.0 |
|
| Chills | General disorders | MedDRA 15.0 |
|
| Feeling Hot | General disorders | MedDRA 15.0 |
|
| Infusion Site Pain | General disorders | MedDRA 15.0 |
|
| Otitis Externa | Infections and infestations | MedDRA 15.0 |
|
| Pharyngitis | Infections and infestations | MedDRA 15.0 |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 15.0 |
|
| C-Reactive Protein Increased | Investigations | MedDRA 15.0 |
|
| Electrocardiogram T Wave Abnormal | Investigations | MedDRA 15.0 |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 |
|
| Headache | Nervous system disorders | MedDRA 15.0 |
|
| Tremor | Nervous system disorders | MedDRA 15.0 |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Ingrown Hair | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Flushing | Vascular disorders | MedDRA 15.0 |
|
| Orthostatic Hypotension | Vascular 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. SPONSOR review can be expedited to meet publication guidelines.
| D004700 | Endocrine System Diseases |