Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK0524A · 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
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Enlicitide, Rosuvastatin |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | obicetrapib, ezetimibe daily |
| AstraZeneca PLC | AZN | 3 | PHASE2 | AZD0780, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| HeartFlow, Inc. | HTFL | 1 | N/A | Rosuvastatin |
MK-0524A is an investigational small molecule being developed for cardiovascular conditions, including primary hypercholesterolemia, mixed hyperlipidemia, dyslipidemia, and flushing. It has been studied in Phase 3 clinical trials for mixed hyperlipidemia and for flushing caused by niacin.
MK-0524A is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The drug has completed Phase 3 clinical trials.
MK-0524A has completed Phase 3 clinical trials. It is an investigational drug and remains in clinical development, with no approval status indicated. Two Phase 3 trials have been completed, along with earlier phase studies.
MK-0524A has been studied in two completed Phase 3 trials: NCT00289900, which enrolled 2,340 participants with mixed hyperlipidemia, and NCT00533611, which enrolled 330 participants to evaluate its effect on flushing caused by niacin. Both trials were randomized, double-blind, and placebo-controlled.
MK-0524A is distinct from MK-0524B. While MK-0524A was studied in Phase 3 trials for mixed hyperlipidemia and flushing, MK-0524B appears in a Phase 1 bioequivalence study (NCT00943124) involving 220 healthy volunteers with dyslipidemia.