Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-7762 (TBD09)
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...
Top 2 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Ganfeborole |
MK-7762 is an investigational small molecule being developed by Merck & Company, Inc. (MRK) for tuberculosis. It is in Phase 1 clinical development. The drug has been studied in a completed Phase 1 trial in healthy adult volunteers.
MK-7762 is being developed for the treatment of tuberculosis. It is an investigational therapy and has not been approved for any indication. The clinical program to date has focused on healthy adult volunteers rather than patients with active tuberculosis.
MK-7762 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program for this investigational tuberculosis candidate.
MK-7762 is in Phase 1 clinical development. One Phase 1 trial has been completed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for tuberculosis or any other indication.
MK-7762 has been studied in one completed Phase 1 trial, NCT05824091, titled Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults. The trial enrolled 119 healthy adult participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, MK-7762 is also known as MK-7762 (TBD09). Both names refer to the same investigational small molecule being developed by Merck & Company, Inc. (MRK) for tuberculosis.