Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK0524B · 1 trial · 1 indication
Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin
Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
Plasma Area Under the Curve of simvastatin
Plasma Area Under the Curve of Laropiprant
Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin
| Arm | Type | Description |
|---|---|---|
| MK0524B then Simvastatin + MK0524A | EXPERIMENTAL | Period 1: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg). Period 2: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets. |
| Simvastatin + MK0524A then MK0524B | EXPERIMENTAL | Period 1: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets. Period 2: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg). |
| Name | Type | Description |
|---|---|---|
| MK0524B (ER niacin (+) laropiprant (+) simvastatin) | DRUG | Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods. |
| MK0524A (ER niacin + laropiprant) | DRUG | Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods. |
| Simvastatin | DRUG | Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods. |
Inclusion Criteria: * Subject is in good health * Subject is a nonsmoker * Subject is willing to follow the study guidelines Exclusion Criteria: * Subject has or has a history of any illness that might confound the results of the study or make participation in the study unsafe for the subject
Top 7 of 10 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Enlicitide |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran, Muvalaplin |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Pelacarsen |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | Obicetrapib |
| AstraZeneca PLC | AZN | 2 | PHASE2 | Rosuvastatin, AZD0780, AZD4954 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
MK0524B is an investigational small molecule combination product developed by Merck & Company, Inc. (ticker MRK) for dyslipidemia, a condition involving abnormal lipid levels in the blood. It combines extended-release niacin, laropiprant, and simvastatin. MK0524B is in Phase 1 clinical development.
MK0524B is being developed for the treatment of dyslipidemia, a cardiovascular condition characterized by abnormal levels of lipids such as cholesterol in the blood. It is an investigational combination product and has not been approved for any indication.
MK0524B is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program evaluating this combination product for dyslipidemia.
MK0524B is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
MK0524B has been evaluated in one completed Phase 1 trial, NCT00943124, titled MK0524B Bioequivalence Study (0524B-070). The trial enrolled 220 healthy adult volunteers aged 18 years and older, was randomized and controlled, and studied dyslipidemia.