Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018654-13 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluated adverse events (AEs), study discontinuation due to AEs, and pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.
This study evaluated AEs, discontinuation due to AEs, and effects on hemodynamic parameters, including systolic blood pressure (SBP) and aortic augmentation index (AIx), following multiple oral doses of MK-8266. Five serial panels, each consisting of eight participants (40 participants in Panels A, B, C, D, and E), were randomized to receive either MK-8266 or matching placebo twice daily (BID) or three times daily (TID) for 10 consecutive days. Although the original plan was to evaluate MK-8266 treatment in Panels D and E using both BID and TID regimens, the study actually evaluated identical TID regimens in these panels.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: MK-8266 BID, 1 mg/Placebo | Experimental | MK-8266 1 mg (0.7 mg in the morning [AM] + 0.3 mg in the evening [PM]), or as matching placebo BID. |
|
| Panel B: MK-8266 BID, 1.8 mg/Placebo | Experimental | MK-8266 1.8 mg (1 mg in the AM + 0.8 mg in the PM), or as matching placebo BID. |
|
| Panel C: MK-8266 TID, 1.8 mg/Placebo | Experimental | MK-8266 TID, 1.8 mg (0.6 mg every 6 hours [q6hr]), or as matching placebo TID. |
|
| Panel D: MK-8266 TID, 2.4 mg/Placebo | Experimental | MK-8266 TID (Panel D), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel D was completed prior to initiation of Panel E. |
|
| Panel E: MK-8266 TID, 2.4 mg/Placebo | Experimental | MK-8266 TID (Panel E), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel E was initiated after completion of Panel D. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8226 BID, 1 mg | Drug | MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up | Assessment of the number of participants with at least one clinical or laboratory AE in those receiving multiple oral doses of MK-8266. 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 sponsor's product, whether or not considered related to the use of the product. | Up to 24 days |
| Participants Receiving MK-8266 or Placebo Who Discontinued Treatment Due to an AE | Assessment of the number of participants receiving MK-8266 who discontinued therapy due to an AE over 10 days of treatment. 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 SPONSOR's product, whether or not considered related to the use of the product. The number of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Days 0-10. | Up to 10 days |
| Change From Baseline in Systolic Blood Pressure (SBP) Following Multiple Oral Doses of MK-8266 or Placebo | Assessment of the change from baseline in SBP, obtained using a validated, semi-automated oscillometric device. Evaluated for MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. | Baseline and Day 10 |
| Heart Rate (HR) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo | Assessment of HR (beats/min) on Day 10 (24-hours postdose) with MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA^0-24hrs). Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Baseline HR values are shown in the Baseline Characteristics section for Panels A, B, C, D, E. |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic Augmentation Index (AIx) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo | Assessment of the central, ascending aortic blood pressure augmentation index (AIx), based on measurement of central pulse pressure at selected time points on Day 10, as measured by applanation tonometry of the radial artery. This outcome measure assessed the time weighted average change over 24 hours postdose (TWA^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Panel A: MK-8266 BID (1 mg) | MK-8266 BID 1 mg, administered as oral capsules (0.7 mg AM + 0.3 mg PM) for 10 days |
| FG001 | Panel A: Placebo BID | Matching placebo capsules, administered orally for 10 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| MK-8266 BID, 1.8 mg | Drug | MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C. |
|
|
| MK-8266 TID, 1.8 mg | Drug | MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D. |
|
|
| MK-8266 TID, 2.4 mg | Drug | MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E. |
|
|
| MK-8266 TID, 2.4 mg | Drug | MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D. |
|
|
| Placebo BID (Panel A) | Drug | Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B. |
|
| Placebo BID (Panel B) | Drug | Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C. |
|
| Placebo TID (Panel C) | Drug | Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D. |
|
| Placebo TID (Panel D) | Drug | Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E. |
|
| Placebo TID (Panel E) | Drug | Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D. |
|
| Day 10 (24 hours postdose) |
| Day 10 |
| Change From Baseline in Cyclic Guanosine Monophosphate (cGMP) Following Multiple Oral Doses of MK-8266 or Placebo | Assessment of whole blood samples for cGMP analysis, based on samples obtained predose as well as 4 and 24 hours postdose on Day 1 and Day 10, and predose only on Day 4. The change from baseline in cGMP was assessed at 24 hours postdose on Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment. | Baseline and Day 10 |
| Percent Inhibition of Platelet Aggregation Induced by Adenosine Diphosphate (ADP) Following Multiple Oral Doses of MK-8266 or Placebo | The percent inhibition of ADP-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of ADP (2.5 µM) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10 only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo. | Baseline and Day 10 (5 hours postdose) |
| Percent Inhibition of Platelet Aggregation Induced by Collagen Following Multiple Oral Doses of MK-8266 or Placebo | The percent inhibition of collagen-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of collagen (2 µg/mL) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10, only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo. | Baseline and Day 10 (5 hours postdose) |
| FG002 | Panel B: MK-8266 BID (1.8 mg) | MK-8266 BID 1.8 mg, administered as oral capsules (1 mg AM + 0.8 mg PM) for 10 days |
| FG003 | Panel B: Placebo BID | Matching placebo capsules, administered orally BID for 10 days |
| FG004 | Panel C: MK-8266 TID (1.8 mg) | MK-8266 0.6 mg TID, administered as oral capsules (1.8 mg) for 10 days |
| FG005 | Panel C: Placebo TID | Matching placebo capsules, administered orally TID for 10 days |
| FG006 | Panel D: MK-8266 TID (2.4 mg) | MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days |
| FG007 | Panel D: Placebo TID | Matching placebo capsules, administered orally TID for 10 days |
| FG008 | Panel E: MK-8266 TID (2.4 mg) | MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days |
| FG009 | Panel E: Placebo TID | Matching placebo capsules, administered orally TID for 10 days |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Panel A: MK-8266 BID, 1 mg | MK-8266 BID 1 mg, administered as oral capsules (0.7 mg AM + 0.3 mg PM) for 10 days, or as matching placebo |
| BG001 | Panel A: Placebo BID | Matching placebo capsules, administered orally for 10 days |
| BG002 | Panel B: MK-8266 BID, 1.8 mg | MK-8266 BID 1 mg, administered as oral capsules (1 mg AM + 0.8 mg PM) for 10 days |
| BG003 | Panel B: Placebo BID | Matching placebo capsules, administered orally for 10 days |
| BG004 | Panel C: MK-8266 TID, 1.8 mg | MK-8266 TID 1.8 mg, administered as oral capsules (0.6 mg q6hr) for 10 days |
| BG005 | Panel C: Placebo TID | Matching placebo capsules, administered orally for 10 days |
| BG006 | Panel D: MK-8266 TID, 2.4 mg | MK-8266 TID 2.4 mg, administered as oral capsules (0.8 mg q6hr) for 10 days |
| BG007 | Panel D: Placebo TID | Matching placebo capsules, administered orally for 10 days |
| BG008 | Panel E: MK-8266 TID, 2.4 mg | MK-8266 TID 2.4 mg, administered as oral capsules (0.8 mg q6hr) for 10 days |
| BG009 | Panel E: Placebo TID | Matching placebo capsules, administered orally for 10 days |
| BG010 | 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 |
| ||||||||||||||||
| Baseline HR | Measurements of HR were obtained in triplicate using a validated, semi-automated oscillometric device, and the triplicate measurements were recorded as median values | All participants who received at least one dose of the investigational drug | Median | Full Range | Beats per minute |
|
| 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 | Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up | Assessment of the number of participants with at least one clinical or laboratory AE in those receiving multiple oral doses of MK-8266. 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 sponsor's product, whether or not considered related to the use of the product. | All participants who received at least one dose of the investigational drug | Posted | Number | Count of Participants | Up to 24 days |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Participants Receiving MK-8266 or Placebo Who Discontinued Treatment Due to an AE | Assessment of the number of participants receiving MK-8266 who discontinued therapy due to an AE over 10 days of treatment. 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 SPONSOR's product, whether or not considered related to the use of the product. The number of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Days 0-10. | All participants who received at least one dose of the investigational drug | Posted | Number | Count of Participants | Up to 10 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Systolic Blood Pressure (SBP) Following Multiple Oral Doses of MK-8266 or Placebo | Assessment of the change from baseline in SBP, obtained using a validated, semi-automated oscillometric device. Evaluated for MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. | All participants who received at least one dose of the investigational drug and had SBP assessments at Baseline and on Day 10 | Posted | Least Squares Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline and Day 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Heart Rate (HR) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo | Assessment of HR (beats/min) on Day 10 (24-hours postdose) with MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA^0-24hrs). Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Baseline HR values are shown in the Baseline Characteristics section for Panels A, B, C, D, E. | All participants who received at least one dose of the investigational drug and had HR assessments 24 hours postdose on Day 10. | Posted | Mean | Standard Deviation | Beats per minute | Day 10 (24 hours postdose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Aortic Augmentation Index (AIx) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo | Assessment of the central, ascending aortic blood pressure augmentation index (AIx), based on measurement of central pulse pressure at selected time points on Day 10, as measured by applanation tonometry of the radial artery. This outcome measure assessed the time weighted average change over 24 hours postdose (TWA^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment. | All participants who received at least one dose of the investigational drug and had AIx assessment on Day 10 | Posted | Least Squares Mean | Standard Deviation | mmHg | Day 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cyclic Guanosine Monophosphate (cGMP) Following Multiple Oral Doses of MK-8266 or Placebo | Assessment of whole blood samples for cGMP analysis, based on samples obtained predose as well as 4 and 24 hours postdose on Day 1 and Day 10, and predose only on Day 4. The change from baseline in cGMP was assessed at 24 hours postdose on Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment. | All participants who received at least one dose of the investigational drug and had cGMP assessments at Baseline and on Day 10 | Posted | Least Squares Mean | Standard Deviation | nanomoles (nM) | Baseline and Day 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Inhibition of Platelet Aggregation Induced by Adenosine Diphosphate (ADP) Following Multiple Oral Doses of MK-8266 or Placebo | The percent inhibition of ADP-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of ADP (2.5 µM) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10 only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo. | All participants who received at least one dose of the investigational drug and had assessment of ADP-induced platelet aggregation on Day 10 | Posted | Mean | Standard Deviation | Percent inhibition | Baseline and Day 10 (5 hours postdose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Inhibition of Platelet Aggregation Induced by Collagen Following Multiple Oral Doses of MK-8266 or Placebo | The percent inhibition of collagen-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of collagen (2 µg/mL) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10, only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo. | All participants who received at least one dose of the investigational drug and had assessment of collagen-induced platelet aggregation on Day 10 | Posted | Mean | Standard Deviation | Percent inhibition | Baseline and Day 10 (5 hours postdose) |
|
11 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panel A: MK-8266 BID, 1 mg | MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days | 0 | 6 | 0 | 6 | 5 | 6 |
| EG001 | Panel A: Placebo BID | Matching placebo capsules, administered orally BID for 10 days | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Panel B: MK-8266 BID, 1.8 mg | MK-8266 1.8 mg (1 mg AM + 0.8 mg PM), administered orally for 10 days | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | Panel B: Placebo BID | Matching placebo capsules, administered orally BID for 10 days | 0 | 2 | 0 | 2 | 1 | 2 |
| EG004 | Panel C: MK-8266 TID, 1.8 mg | MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | Panel C: Placebo TID | Matching placebo capsules, administered orally TID for 10 days | 0 | 2 | 0 | 2 | 1 | 2 |
| EG006 | Panel D: MK-8266 TID, 2.4 mg | MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days | 0 | 6 | 0 | 6 | 4 | 6 |
| EG007 | Panel D: Placebo TID | Matching placebo capsules, administered orally TID for 10 days | 0 | 2 | 0 | 2 | 1 | 2 |
| EG008 | Panel E: MK-8266 TID, 2.4 mg | MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days | 0 | 6 | 0 | 6 | 5 | 6 |
| EG009 | Panel E: Placebo TID | Matching placebo capsules, administered orally TID for 10 days | 0 | 2 | 0 | 2 | 2 | 2 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abnormal sensation in eye | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sluggishness | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | 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 timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Male |
|
Matching placebo capsules, administered orally BID for 10 days |
| OG004 | Panel C: MK-8266 TID, 1.8 mg | MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days |
| OG005 | Panel C: Placebo | Matching placebo capsules, administered orally TID for 10 days |
| OG006 | Panel D: MK-8266 TID (2.4 mg) | MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days |
| OG007 | Panel D: Placebo | Matching placebo capsules, administered orally TID for 10 days |
| OG008 | Panel E: MK-8266 2.4 mg TID | MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days |
| OG009 | Panel E: Placebo | Matching placebo capsules, administered orally TID for 10 days |
|
|
MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E. |
| OG004 | Pooled Placebo | Matching placebo capsules from Panels A, B, C, D & E, administered orally BID or TID for 10 days |
|
|
|
MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E. |
| OG004 | Pooled Placebo | Matching placebo capsules, administered orally TID for 10 days |
|
|
|
| Panels D & E Combined: MK-8266 TID, 2.4 mg |
MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E. |
| OG004 | Pooled Placebo | Matching placebo capsules from Panels A, B, C, D & E, administered orally BID or TID for 10 days |
|
|
|
MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E. |
| OG004 | Pooled Placebo | Matching placebo capsules from Panels A, B, C, D & E, administered orally BID or TID for 10 days |
|
|
|
|
|
|
|