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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy volunteers in the context of a first-in-human study. The effect of food on the rate and extent of absorption of a single oral dose of MK-7762 (TBD09) will also be evaluated.
This is a 2-part blinded, placebo-controlled, combined single ascending dose with a food effect cohort and multiple ascending dose trial to be conducted in one trial center in the United States.
Part 1 has a single ascending dose (SAD) design with up to 5 planned dose levels. Based on the interim PK results reviewed for the dose escalation decisions, a dose will be selected for administration to a sixth cohort both in fed and fasted states to evaluate the effect of food on MK-7762 (TBD09).
Safety will be assessed throughout the study; cardiac monitoring/serial ECGs and serial blood samples will be collected for the safety and PK assessment of MK7762 (TBD09). Dose escalation to the next cohort (i.e., dose level) will not take place until the Sponsor, in conjunction with the Principal Investigator, has determined that adequate safety, tolerability (and PK for the later cohorts) from the previous cohort has been demonstrated to permit proceeding to the next cohort.
Interim PK analyses will be performed for the dose escalation decisions (after cohorts 1 and 2 are completed), to select the intermediate dose for the food effect cohort, and to reconsider the sampling time points as the trial progresses. All samples will be sent for analysis and the bioanalytical lab will be unblinded and only run the analysis on active treatment participants. At the escalation meetings, PK analyses from active treatment participants and blinded (pooled) safety summaries will be reviewed.
All participants in Part 1 will remain at the trial site from Day -1 until their end of-trial visit (approximately 8 days for Cohorts 1-5 and 16 days for Cohort 6).
At the end of Part 1, pharmacokinetic and unblinded safety data along with dose rationale for Part 2 will be sent to the Food and Drug Administration (FDA) for review and approval. The trial will not proceed to Part 2 until the FDA provides approval.
Part 2 has a multiple ascending dose (MAD) design. The dose cohorts for Part 2 will be determined based on model predictions to determine the steady-state Cmax exposure, and safety from Part 1.
In this MAD part, each participant will be administered MK7762 or matching placebo for 28 days with corresponding PK measurements. Three dose cohorts are planned. After each dose cohort, the Sponsor and Investigator will review the PK and safety data before proceeding to the next dose level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-7762 (TBD09) | Experimental | In Part 1 of the trial (SAD/FE), up to five sequential cohorts will be enrolled to evaluate up to five escalating single doses of MK-7762; 8 participants in each cohort will be randomized (3:1) to receive MK-7762 or placebo. A sixth cohort will evaluate the effect of food on PK of single doses of MK-7762 utilizing an open-label, two-period design in 8 participants. |
|
| Placebo | Placebo Comparator | Participants will receive placebos matched to MK-7762 (TBD09). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-7762 (TBD09) | Drug | Cohort 1: 50 mg Cohort 2: 150 mg Cohort 3: 300 mg Cohort 4: 600 mg Cohort 5: TBD Cohort 6: TBD |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor. | Day 1 through Day 7 |
| Part 1: Percentage of Participants Reporting TEAEs by Severity | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal. | Day 1 through Day 7 |
| Part 1: Percentage of Participants Reporting Study Drug Related TEAEs | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Plasma Drug Concentration (Cmax) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. |
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Inclusion Criteria:
To be included in this trial, an individual must satisfy all the following criteria:
Exclusion Criteria:
If an individual meets any of the following criteria, they are ineligible for this trial:
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| Name | Affiliation | Role |
|---|---|---|
| Gates MRI | Gates MRI | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Lincoln | Nebraska | 68502 | United States |
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A total of 119 participants (including 2 replacement participants in Part 2) were dosed (48 in Part 1 and 71 in Part 2), and a total of 97 participants were exposed to MK-7762 (38 from Part 1 and 59 from Part 2).
This was a first-in-human trial of MK-7762, administered orally to healthy adults. It was a randomized, placebo-controlled, two-part trial. Part 1 consisted of double-blind single ascending dose (SAD) Cohorts 1 to 5, and food effect (FE) Cohort 6 (open-label). Part 2 consisted of a FE cohort 7 (open-label) and three sequential double-blind multiple ascending dose (MAD) cohorts (Cohorts 8 to 10).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Cohort 1: SAD MK-7762 50 Milligrams (mg) Fasted | Participants were randomized to receive a single dose of MK-7762 50 mg. |
| FG001 | Part 1: Cohort 2: SAD MK-7762 150 mg Fasted | Participants were randomized to receive a single dose of MK-7762 150 mg. |
| FG002 | Part 1: Cohort 3: SAD MK-7762 300 mg Fasted | Participants were randomized to receive a single dose of MK-7762 300 mg. |
| FG003 | Part 1: Cohort 4: SAD MK-7762 600 mg Fasted | Participants were randomized to receive a single dose of MK-7762 600 mg. |
| FG004 | Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted | Participants were randomized to receive a single dose of MK-7762 1200 mg. |
| FG005 | Part 1: Placebo (Pooled) | Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg. |
| FG006 | Part 1: Cohort 6: FE MK-7762 300 mg, Sequence: Fasted/Fed | Participants were administered a single dose of MK-7762 in an open-label, cross-over design (fasted followed by fed condition) to evaluate the effect of food on pharmacokinetics (PK). Each treatment sequence was separated by a washout period of 8 Days. |
| FG007 | Part 1: Cohort 6: FE MK-7762 300 mg, Sequence: Fed/Fasted | Participants were administered a single dose of MK-7762 in an open-label, cross-over design (fed followed by fasted condition) to evaluate the effect of food on PK. Each treatment sequence was separated by a washout period of 8 Days. |
| FG008 | Part 2: Cohort 7: FE 600 mg MK-7762, Sequence: Fasted/Standard/High-Fat | The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in the fasted state, followed by treatment in a fed state with standard meal breakfast, followed by treatment in a fed state with high-fat meal breakfast. Treatment periods in the sequence were separated by a washout period of 8 days. |
| FG009 | Part 2: Cohort 7: FE 600 mg MK-7762 Sequence: Standard/High-Fat/Fasted | The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in a fed state with a standard meal breakfast, followed by treatment in a fed state with a high-fat meal breakfast, followed by treatment in a fasted state. Treatment periods in the sequence were separated by a washout period of 8 days. |
| FG010 | Part 2: Cohort 7: FE 600 mg MK-7762 Sequence: High-Fat/Fasted/Standard | The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in a fed state with a high-fat meal breakfast, followed by treatment in a fasted state, followed by treatment in a fed state with a standard meal breakfast. Treatment periods in the sequence were separated by a washout period of 8 days. |
| FG011 | Part 2: Cohort 8: MAD MK-7762 100 mg Fasted | Participants were randomized to receive MK-7762 100 mg in fasted state. |
| FG012 | Part 2: Cohort 9: MAD MK-7762 300 mg Fasted | Participants were randomized to receive MK-7762 300 mg in fasted state. |
| FG013 | Part 2: Cohort 10: MAD MK-7762 500 mg Fasted | Participants were randomized to receive MK-7762 500 mg in fasted state. |
| FG014 | Part 2: Cohort 8: MAD MK-7762 100 mg Fed | Participants were randomized to receive MK-7762 100 mg in fed state with a standard meal breakfast. |
| FG015 | Part 2: Cohort 9: MAD MK-7762 300 mg Fed | Participants were randomized to receive MK-7762 300 mg in fed state with a standard meal breakfast. |
| FG016 | Part 2: Cohort 10: MAD MK-7762 500 mg Fed | Participants were randomized to receive MK-7762 500 mg in fed state with a standard meal breakfast. |
| FG017 | Part 2: Placebo (Pooled) | Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1: SAD Cohorts (Up to Day 7) |
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| Part1: Period 1 FE Cohort 6(Up to Day 7) |
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| Part1: Washout Period (8 Days) |
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| Part1: Period 2 FE Cohort 6(Up to Day 7) |
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| Part 2:Period 1 FE Cohort 7(Up to Day 8) |
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| Part2: Washout Period ( 8 Days) |
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| Part 2:Period 2 FE Cohort 7(Up to Day 8) |
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| Part2: Washout Period (8 Days) |
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| Part 2:Period 3 FE Cohort 7(Up to Day 8) |
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| Part 2: MAD Cohorts (Up to Day 36) |
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Safety Population comprised of all participants who received the study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Cohort 1: SAD MK-7762 50 Milligrams (mg) Fasted | Participants were randomized to receive a single dose of MK-7762 50 mg. |
| BG001 | Part 1: Cohort 2: SAD MK-7762 150 mg Fasted |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor. | Safety Population. | Posted | Number | Percentage of participants | Day 1 through Day 7 |
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Part 1 Cohorts 1-5 and Placebo: up to 7 days, Part 1 Cohort 6: up to 22 days (up to 7 days for each Crossover Period and 8 days Washout), Part 2 Cohort 7: up to 40 days (up to 8 days for each Crossover Period and 8 days for each Washout), Part 2 Cohorts 8-10 and Placebo: up to 36 days
Treatment emergent adverse events were collected in Safety Population who has received at least one dose of study intervention. The adverse events in Part 1 FE Cohort 6 and in Part 2 FE and MAD Cohorts (7 to 10) were collected in participants as per the dose levels received regardless of the fasting conditions.
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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 | Part 1: Cohort 1: SAD MK-7762 50 Milligrams (mg) Fasted | Participants were randomized to receive a single dose of MK-7762 50 mg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Gates MRI | 18577022108 | clinical.trials@gatesmri.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2023 | Mar 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2024 | Mar 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Placebo | Other | A subset of participants from each of the 6 dosing cohorts will receive placebo. |
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| Day 1 through Day 7 |
| Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs, SAEs, and AESIs | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor. | Up to Day 7 |
| Part 2: FE Cohort 7: Percentage of Participants Reporting Study Drug Related TEAEs | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. | Up to Day 7 |
| Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs by Severity | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal. | Up to Day 7 |
| Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs, SAEs, and AESIs | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor. | Day 1 through Day 36. |
| Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs by Severity | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal. | Day 1 through Day 36. |
| Part 2: MAD Cohorts: Proportion of Participants Reporting Study Drug Related TEAEs | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. | Day 1 through Day 36 |
| Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and white blood cells [WBC]); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count | Up to Day 7 |
| Part 1: Number of Participants With Clinically Significant Changes in Chemistry Parameters | Blood samples were collected for the analysis of chemistry parameters: alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total and direct bilirubin, creatinine, blood urea nitrogen (BUN) or urea, creatine kinase, sodium, potassium, bicarbonate or CO2, chloride, glucose, and lipid profile (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. | Up to Day 7 |
| Part 1: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters | Blood samples were collected for the analysis of Serum coagulation parameters: Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and international normalized ratio (INR). | Up to Day 7 |
| Part 1: Number of Participants With Clinically Significant Changes in Urinalysis | Urine samples were collected for the analysis of urinalysis parameters: Dipstick for potential of hydrogen (pH), specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites. | Up to Day 7 |
| Part 1: Number of Participants With Clinically Significant Changes in Vital Parameters | Vital parameters including temperature, heart rate (HR), and blood pressure (BP) were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented. | Up to Day 7 |
| Part 1: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected by Fridericia's formula (QTcF). | Up to Day 7 |
| Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and WBC); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count. | Up to Day 8 |
| Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and WBC); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count | Up to Day 36 |
| Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Chemistry Parameters | Blood samples were collected for the analysis of chemistry parameters: ALT, AST, ALP, total and direct bilirubin, creatinine, BUN or urea, creatine kinase, sodium, potassium, bicarbonate or CO2, chloride, glucose, and lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides). | Up to Day 8 |
| Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Chemistry Parameters | Participants were randomized to receive MK-7762 100 mg in a fed or fasted state. | Up to Day 36 |
| Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters | Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR. | Up to Day 8 |
| Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Urinalysis | Urine samples were collected for the analysis of urinalysis parameters: Dipstick for pH, specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites. | Up to Day 8 |
| Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters | Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR. | Up to Day 36 |
| Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Urinalysis | Urine samples were collected for the analysis of urinalysis parameters: Dipstick for pH, specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites | Up to Day 36 |
| Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Vital Parameters | Vital parameters including temperature, HR, and BP were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented. | Up to Day 8 |
| Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Vital Parameters | Vital parameters including temperature, HR, and BP were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented. | Up to Day 36 |
| Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in ECG Parameters | ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF. | Up to Day 8 |
| Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in ECG Parameters | ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF. | Up to Day 36 |
| Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
| Part 1: Time to Maximum Plasma Drug Concentration (Tmax) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
| Part 1: Area Under the Concentration-time Curve (AUC) Calculated to Last Quantifiable Observed Sample (AUClast) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
| Part 1: AUC Over First 24h (AUC0-24) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Up to 24 hrs post dose |
| Part 1: AUC Extrapolated to Infinity (AUC0-inf) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
| Part 1: Terminal Elimination Half-life (t½) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
| Part 1: Oral Clearance (CL/F) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
| Part 1: Oral Volume of Distribution (Vd/F) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
| Part 2: FE Cohort 7: Cmax of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
| Part 2: FE Cohort 7: Tmax of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
| Part 2: FE Cohort 7: AUClast of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
| Part 2: FE Cohort 7: AUC0-inf of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
| Part 2: FE Cohort 7: AUC0-24 of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Up to 24 hours post dose |
| Part 2: FE Cohort 7: t½ of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
| Part 2: FE Cohort 7: CL/F of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
| Part 2: FE Cohort 7: Vd/F of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
| Part 2: MAD Cohorts: CL/F of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose |
| Part 2: MAD Cohorts: Vz/F of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose |
| Part 2: MAD Cohorts: Accumulation Ratio (RA AUC0-24) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. Accumulation ratio based on AUC 0-24 was calculated as AUC tau (Day 28) /AUC 0-24 (Day 1). | Day 1: predose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose |
| Part 2: MAD Cohorts: Cmax of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose |
| Part 2: MAD Cohorts: Tmax of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose |
| Part 2: MAD Cohorts: AUC0-24 of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Up to 24 hours post dose |
| Part 2: MAD Cohorts: AUClast of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose |
| Part 2: MAD Cohorts: AUC0-inf of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose |
| Part 2: MAD Cohorts: AUC0-24 of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 28: pre-dose, and at 1, 2, 4, 6, 8, 12 and 24 hours postdose |
| Part 2: MAD Cohorts: t1/2 of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose |
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Participants were randomized to receive a single dose of MK-7762 150 mg.
| BG002 | Part 1: Cohort 3: SAD MK-7762 300 mg Fasted | Participants were randomized to receive a single dose of MK-7762 300 mg. |
| BG003 | Part 1: Cohort 4: SAD MK-7762 600 mg Fasted | Participants were randomized to receive a single dose of MK-7762 600 mg. |
| BG004 | Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted | Participants were randomized to receive a single dose of MK-7762 1200 mg. |
| BG005 | Part 1: Placebo (Pooled) | Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg. |
| BG006 | Part 1: Cohort 6: FE MK-7762 300 mg, Sequence: Fasted/Fed | Participants were administered a single dose of MK-7762 in an open-label, cross-over design (fasted followed by fed condition) to evaluate the effect of food on pharmacokinetics (PK). Each treatment sequence was separated by a washout period of 8 Days. |
| BG007 | Part 1: Cohort 6: FE MK-7762 300 mg, Sequence: Fed/Fasted | Participants were administered a single dose of MK-7762 in an open-label, cross-over design (fed followed by fasted condition) to evaluate the effect of food on PK. Each treatment sequence was separated by a washout period of 8 Days. |
| BG008 | Part 2: Cohort 7: FE 600 mg MK-7762, Sequence: Fasted/Standard/High-Fat | The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in the fasted state, followed by treatment in a fed state with standard meal breakfast, followed by treatment in a fed state with high-fat meal breakfast. Treatment periods in the sequence were separated by a washout period of 8 days. |
| BG009 | Part 2: Cohort 7: FE 600 mg MK-7762 Sequence: Standard/High-Fat/Fasted | The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in a fed state with a standard meal breakfast, followed by treatment in a fed state with a high-fat meal breakfast, followed by treatment in a fasted state. Treatment periods in the sequence were separated by a washout period of 8 days. |
| BG010 | Part 2: Cohort 7: FE 600 mg MK-7762 Sequence: High-Fat/Fasted/Standard | The FE Cohort 7 was an open-label, 3-period evaluation of 600 mg MK-7762 in a fed state with a high-fat meal breakfast, followed by treatment in a fasted state, followed by treatment in a fed state with a standard meal breakfast. Treatment periods in the sequence were separated by a washout period of 8 days. |
| BG011 | Part 2: Cohort 8: MAD MK-7762 100 mg Fasted | Participants were randomized to receive MK-7762 100 mg in fasted state. |
| BG012 | Part 2: Cohort 9: MAD MK-7762 300 mg Fasted | Participants were randomized to receive MK-7762 300 mg in fasted state. |
| BG013 | Part 2: Cohort 10: MAD MK-7762 500 mg Fasted | Participants were randomized to receive MK-7762 500 mg in fasted state. |
| BG014 | Part 2: Cohort 8: MAD MK-7762 100 mg Fed | Participants were randomized to receive MK-7762 100 mg in fed state with a standard meal breakfast. |
| BG015 | Part 2: Cohort 9: MAD MK-7762 300 mg Fed | Participants were randomized to receive MK-7762 300 mg in fed state with a standard meal breakfast. |
| BG016 | Part 2: Cohort 10: MAD MK-7762 500 mg Fed | Participants were randomized to receive MK-7762 500 mg in fed state with a standard meal breakfast. |
| BG017 | Part 2: Placebo (Pooled) | Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg. |
| BG018 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Participants were randomized to receive a single dose of MK-7762 50 mg. |
| OG001 | Part 1: Cohort 2: SAD MK-7762 150 mg Fasted | Participants were randomized to receive a single dose of MK-7762 150 mg. |
| OG002 | Part 1: Cohort 3: SAD MK-7762 300 mg Fasted | Participants were randomized to receive a single dose of MK-7762 300 mg. |
| OG003 | Part 1: Cohort 4: SAD MK-7762 600 mg Fasted | Participants were randomized to receive a single dose of MK-7762 600 mg. |
| OG004 | Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted | Participants were randomized to receive a single dose of MK-7762 1200 mg. |
| OG005 | Part 1: Placebo (Pooled) | Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg. |
| OG006 | Part 1: Cohort 6: FE MK-7762 300 mg Fasted | Participants were administered a single dose of MK-7762 300 mg in fasted condition. |
| OG007 | Part 1: Cohort 6: FE MK-7762 300 mg Fed | Participants were administered a single dose of MK-7762 300 mg in fed condition. |
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| Primary | Part 1: Percentage of Participants Reporting TEAEs by Severity | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal. | Safety Population. | Posted | Number | Percentage of participants | Day 1 through Day 7 |
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| Primary | Part 1: Percentage of Participants Reporting Study Drug Related TEAEs | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. | Safety Population. | Posted | Number | Percentage of participants | Day 1 through Day 7 |
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| Primary | Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs, SAEs, and AESIs | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor. | Safety Population. | Posted | Number | Percentage of participants | Up to Day 7 |
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| Primary | Part 2: FE Cohort 7: Percentage of Participants Reporting Study Drug Related TEAEs | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. | Safety Population. | Posted | Number | Percentage of participants | Up to Day 7 |
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| Primary | Part 2: FE Cohort 7: Percentage of Participants Reporting TEAEs by Severity | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal. | Safety Population. | Posted | Number | Percentage of participants | Up to Day 7 |
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| Primary | Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs, SAEs, and AESIs | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction. AESIs are adverse events that the Sponsor monitored carefully and were subject to expedited reporting to the Sponsor. | Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status. | Posted | Number | Percentage of participants | Day 1 through Day 36. |
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| Primary | Part 2: MAD Cohorts: Percentage of Participants Reporting TEAEs by Severity | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. The intensity for each AE reported during the study were assigned to 1 of 5 categories: Grade 1 Mild symptoms, causing no or minimal interference with usual social and functional activities with intervention not indicated; Grade 2 Moderate symptoms, causing greater than minimal interference with usual social and functional activities with intervention indicated; Grade 3 Severe symptoms, causing inability to perform usual social and functional activities with intervention or hospitalization indicated; Grade 4 Potentially life-threatening symptoms, causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death and Grade 5: Fatal. | Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status. | Posted | Number | Percentage of participants | Day 1 through Day 36. |
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| Primary | Part 2: MAD Cohorts: Proportion of Participants Reporting Study Drug Related TEAEs | An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. | Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status. | Posted | Number | Percentage of participants | Day 1 through Day 36 |
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| Primary | Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and white blood cells [WBC]); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count | Safety Population. | Posted | Count of Participants | Participants | Up to Day 7 |
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| Primary | Part 1: Number of Participants With Clinically Significant Changes in Chemistry Parameters | Blood samples were collected for the analysis of chemistry parameters: alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total and direct bilirubin, creatinine, blood urea nitrogen (BUN) or urea, creatine kinase, sodium, potassium, bicarbonate or CO2, chloride, glucose, and lipid profile (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 7 |
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| Primary | Part 1: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters | Blood samples were collected for the analysis of Serum coagulation parameters: Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and international normalized ratio (INR). | Safety Population. | Posted | Count of Participants | Participants | Up to Day 7 |
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| Primary | Part 1: Number of Participants With Clinically Significant Changes in Urinalysis | Urine samples were collected for the analysis of urinalysis parameters: Dipstick for potential of hydrogen (pH), specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 7 |
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| Primary | Part 1: Number of Participants With Clinically Significant Changes in Vital Parameters | Vital parameters including temperature, heart rate (HR), and blood pressure (BP) were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 7 |
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| Primary | Part 1: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected by Fridericia's formula (QTcF). | Safety Population. | Posted | Count of Participants | Participants | Up to Day 7 |
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| Primary | Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and WBC); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 8 |
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| Primary | Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples were collected for the analysis of hematology parameters: complete blood count (red blood cells, hemoglobin, platelets, and WBC); red blood cell parameters (eg, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width); white blood cell differential (absolute counts), including neutrophils, lymphocytes, monocytes, eosinophils and basophils; and reticulocyte count | Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status. | Posted | Count of Participants | Participants | Up to Day 36 |
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| Primary | Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Chemistry Parameters | Blood samples were collected for the analysis of chemistry parameters: ALT, AST, ALP, total and direct bilirubin, creatinine, BUN or urea, creatine kinase, sodium, potassium, bicarbonate or CO2, chloride, glucose, and lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides). | Safety Population. | Posted | Count of Participants | Participants | Up to Day 8 |
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| Primary | Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Chemistry Parameters | Participants were randomized to receive MK-7762 100 mg in a fed or fasted state. | Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status. | Posted | Count of Participants | Participants | Up to Day 36 |
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| Primary | Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters | Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 8 |
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| Primary | Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Urinalysis | Urine samples were collected for the analysis of urinalysis parameters: Dipstick for pH, specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 8 |
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| Primary | Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters | Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR. | Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status. | Posted | Count of Participants | Participants | Up to Day 36 |
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| Primary | Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Urinalysis | Urine samples were collected for the analysis of urinalysis parameters: Dipstick for pH, specific gravity, glucose, protein, blood, leukocyte esterase, nitrites, ketones, bilirubin, and urobilinogen. Microscopic examination for red blood cells, white blood cells, casts, and bacteria was performed if urine dipstick is positive for protein, blood, leukocyte esterase, or nitrites | Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status. | Posted | Count of Participants | Participants | Up to Day 36 |
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| Primary | Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in Vital Parameters | Vital parameters including temperature, HR, and BP were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 8 |
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| Primary | Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in Vital Parameters | Vital parameters including temperature, HR, and BP were measured in supine position. Data for number of participants with abnormal clinically significant changes for vital signs have been presented. | Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status. | Posted | Count of Participants | Participants | Up to Day 36 |
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| Primary | Part 2: FE Cohort 7: Number of Participants With Clinically Significant Changes in ECG Parameters | ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 8 |
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| Primary | Part 2: MAD Cohorts: Number of Participants With Clinically Significant Changes in ECG Parameters | ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF. | Safety Population. Data were collected across MAD cohorts based on dose levels, regardless of fasting status. | Posted | Count of Participants | Participants | Up to Day 36 |
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| Secondary | Part 1: Maximum Plasma Drug Concentration (Cmax) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Pharmacokinetic Population comprised of all participants who received MK-7762 and have at least one non-zero pharmacokinetic result available. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micromoles | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
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| Secondary | Part 1: Time to Maximum Plasma Drug Concentration (Tmax) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Pharmacokinetic Population. | Posted | Median | Full Range | Hours | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
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| Secondary | Part 1: Area Under the Concentration-time Curve (AUC) Calculated to Last Quantifiable Observed Sample (AUClast) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*micromoles | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
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| Secondary | Part 1: AUC Over First 24h (AUC0-24) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*micromoles | Up to 24 hrs post dose |
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| Secondary | Part 1: AUC Extrapolated to Infinity (AUC0-inf) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*micromoles | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
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| Secondary | Part 1: Terminal Elimination Half-life (t½) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
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| Secondary | Part 1: Oral Clearance (CL/F) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Pharmacokinetic Population. Only those participants with data available at specified time points have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
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| Secondary | Part 1: Oral Volume of Distribution (Vd/F) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. In FE cohort 6 for fasted and fed conditions, data has been collected for all fasted and fed participants. The data hence has been presented for all fasted and fed participants. | Pharmacokinetic Population. Only those participants with data available at specified time points have been presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Day 1: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose and 24 and 36 hours post-dose (Day 2); Day 3: 48 hours post-dose; Day 4: 72 hours post-dose; Day 7: Within ±1-hour time window of time of study drug administration on Day 1 |
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| Secondary | Part 2: FE Cohort 7: Cmax of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
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| Secondary | Part 2: FE Cohort 7: Tmax of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Median | Full Range | Hours | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
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| Secondary | Part 2: FE Cohort 7: AUClast of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
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| Secondary | Part 2: FE Cohort 7: AUC0-inf of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
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| Secondary | Part 2: FE Cohort 7: AUC0-24 of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Up to 24 hours post dose |
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| Secondary | Part 2: FE Cohort 7: t½ of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
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| Secondary | Part 2: FE Cohort 7: CL/F of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
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| Secondary | Part 2: FE Cohort 7: Vd/F of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose and 24- and 36-hours post-dose (Day 2); Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6: 120 hours; Day 7: 144 hours; Day 8: 168 hours post dose |
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| Secondary | Part 2: MAD Cohorts: CL/F of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose |
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| Secondary | Part 2: MAD Cohorts: Vz/F of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose |
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| Secondary | Part 2: MAD Cohorts: Accumulation Ratio (RA AUC0-24) of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. Accumulation ratio based on AUC 0-24 was calculated as AUC tau (Day 28) /AUC 0-24 (Day 1). | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Day 1: predose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose |
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| Secondary | Part 2: MAD Cohorts: Cmax of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose |
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| Secondary | Part 2: MAD Cohorts: Tmax of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Median | Full Range | Hours | Day 1: pre-dose and at 1, 2, 4, 6, 8, and 12 hours post dose; Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose |
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| Secondary | Part 2: MAD Cohorts: AUC0-24 of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Up to 24 hours post dose |
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| Secondary | Part 2: MAD Cohorts: AUClast of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours postdose |
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| Secondary | Part 2: MAD Cohorts: AUC0-inf of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose |
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| Secondary | Part 2: MAD Cohorts: AUC0-24 of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | Day 28: pre-dose, and at 1, 2, 4, 6, 8, 12 and 24 hours postdose |
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| Secondary | Part 2: MAD Cohorts: t1/2 of MK-7762 | Blood samples were collected at indicated time points for the analysis of pharmacokinetic parameters. Pharmacokinetics data was calculated using standard non-compartmental analysis methods. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Day 28: pre-dose, and at 1, 2, 4, 6, 8, and 12 hours post dose |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Part 1: Cohort 2: SAD MK-7762 150 mg Fasted | Participants were randomized to receive a single dose of MK-7762 150 mg. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Part 1: Cohort 3: SAD MK-7762 300 mg Fasted | Participants were randomized to receive a single dose of MK-7762 300 mg. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Part 1: Cohort 4: SAD MK-7762 600 mg Fasted | Participants were randomized to receive a single dose of MK-7762 600 mg. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Part 1: Cohort 5: SAD MK-7762 1200 mg Fasted | Participants were randomized to receive a single dose of MK-7762 1200 mg. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | Part 1: Placebo (Pooled) | Participants were randomized to receive a single dose of placebo in capsule sizes matching MK-7762 10 mg, 100 mg, and/or 300 mg. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG006 | Part 1: Cohort 6: FE MK-7762 300 mg Fasted | Participants were administered a single dose of MK-7762 300 mg in fasted condition. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG007 | Part 1: Cohort 6: FE MK-7762 300 mg Fed | Participants were administered a single dose of MK-7762 300 mg in fed condition. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG008 | Part 2: Cohort 7: FE 600 mg Fasted | Participants were administered with 600 mg MK-7762 in a fasted state. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG009 | Part 2: Cohort 7: FE 600 mg Fed-Standard Meal | Participants were administered with 600 mg MK-7762 after a standard meal breakfast. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG010 | Part 2: Cohort 7: FE 600 mg Fed High-fat Meal | Participants were administered with 600 mg MK-7762 after a high-fat meal breakfast. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG011 | Part 2: Cohort 8: MAD MK-7762 100 mg | Participants were randomized to receive MK-7762 100 mg in a fed or fasted state. | 0 | 16 | 0 | 16 | 12 | 16 |
| EG012 | Part 2: Cohort 9: MAD MK-7762 300 mg | Participants were randomized to receive MK-7762 300 mg in a fed or fasted state. | 0 | 16 | 0 | 16 | 10 | 16 |
| EG013 | Part 2: Cohort 10: MAD MK-7762 500 mg | Participants were randomized to receive MK-7762 500 mg in a fed or fasted state. | 0 | 16 | 0 | 16 | 14 | 16 |
| EG014 | Part 2: Placebo (Pooled) | Participants were randomized to receive placebo in fasted state or in fed state with standard breakfast meal in capsule sizes matching MK-7762 100 mg and/or 300 mg. | 0 | 12 | 0 | 12 | 8 | 12 |
| Dry Eye | Eye disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Ocular Discomfort | Eye disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Vitreous Floaters | Eye disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Hypertrophy Of Tongue Papillae | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Paraesthesia Oral | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Medical Device Site Reaction | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Nodule | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Sensation Of Foreign Body | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Thirst Decreased | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Muscle Twitching | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Decreased Vibratory Sense | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Intermenstrual Bleeding | Reproductive system and breast disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Nipple Pain | Reproductive system and breast disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Nail Cuticle Fissure | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
Not provided
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Any AESI |
|
| Title | Measurements |
|---|---|
|
| Severe |
|
| Any SAE |
|
| Any AESI |
|
| Moderate |
|
| Severe |
|