Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-7762 · 1 trial · 1 indication
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Blood samples were collected for the analysis of Serum coagulation parameters: Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and international normalized ratio (INR).
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.
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.
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected by Fridericia's formula (QTcF).
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.
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
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).
Participants were randomized to receive MK-7762 100 mg in a fed or fasted state.
Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR.
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.
Blood samples were collected for the analysis of Serum coagulation parameters: PT, PTT, and INR.
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
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.
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.
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF.
ECG parameters included HR, RR interval, PR interval, QRS duration, QT interval, and QTcF.
| Arm | Type | Description |
|---|---|---|
| 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). |
| Name | Type | Description |
|---|---|---|
| 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 |
| Placebo | OTHER | A subset of participants from each of the 6 dosing cohorts will receive placebo. |
Inclusion Criteria: To be included in this trial, an individual must satisfy all the following criteria: 1. Is ≥ 19 to ≤ 55 years of age. 2. Is healthy as determined by the Investigator via medical history and clinical examination before enrollment in the trial. 3. Can understand and comply with t...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
MK-7762 is an investigational small molecule being developed for tuberculosis. It is currently in Phase 1 clinical development and is not approved by the FDA. The drug is being studied for its safety, tolerability, pharmacokinetics, and food effect in healthy adults.
MK-7762 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy adults.
MK-7762 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for tuberculosis.
MK-7762 has one completed Phase 1 clinical trial, identified as NCT05824091. This trial evaluated the safety, tolerability, pharmacokinetics, and food effect of MK-7762 in healthy adults in the United States. The trial enrolled 119 participants and was randomized, double-blind, and placebo-controlled.
MK-7762 is not known to have any alternative names. It is a distinct investigational small molecule being developed by Merck & Company, Inc. for tuberculosis. No other names for this drug have been reported.