Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-2828 · 4 trials · 5 indications
Blood samples will be collected to determine the AUC0-inf of rosuvastatin.
Blood samples will be collected to determine the AUC0-inf of furosemide.
Blood samples will be collected at multiple time points to determine the AUC0-inf of MK-2828.
Blood samples will be collected at multiple time points to determine the Cmax of MK-2828.
Blood samples will be collected at multiple time points to determine the AUC0-inf of Midazolam.
Blood samples will be collected at multiple time points to determine the Cmax of Midazolam.
Blood samples will be collected to determine the AUC0-inf of MK-2828
Blood samples will be collected to determine the AUC0-last of MK-2828
Blood samples will be collected to determine the AUC0-24 of MK-2828
Blood samples will be collected to determine the Cmax of MK-2828
Blood samples will be collected to determine the Tmax of MK-2828
Blood samples will be collected to determine the C24 of MK-2828
Blood samples will be collected to determine the t1/2 of MK-2828
Blood samples will be collected to determine the CL/F of MK-2828
Blood samples will be collected to determine the Vz/F of MK-2828
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
| Arm | Type | Description |
|---|---|---|
| Rosuvastatin + MK-2828 | EXPERIMENTAL | Participants receive rosuvastatin and MK-2828 orally. |
| Furosemide + MK-2828 | EXPERIMENTAL | Participants receive furosemide and MK-2828 orally. |
| Part 1: Itraconazole | EXPERIMENTAL | Participants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828. |
| Part 2: Midazolam | EXPERIMENTAL | Participants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam. |
| Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment will receive a single dose of MK-2828 on Day 1 |
| End Stage Renal Disease (ESRD) on Hemodialysis (HD) | EXPERIMENTAL | Participants with ESRD will receive a single dose of MK-2828 on Day 1 in each of 2 periods, with a washout of at least 14 days between doses. |
| Healthy Mean Matched Control | EXPERIMENTAL | Participants with normal renal function will receive a single dose of MK-2828 on Day 1 |
| MK-2828 | EXPERIMENTAL | Participants receive daily MK-2828 for 28 days. |
| Placebo | PLACEBO_COMPARATOR | Participants receive daily placebo for 28 days. |
| Name | Type | Description |
|---|---|---|
| Rosuvastatin | DRUG | Oral administration |
| Furosemide | DRUG | Oral administration |
| MK-2828 | DRUG | Oral administration |
| Itraconazole | DRUG | Administered orally as syrup |
| Midazolam | DRUG | Administered orally as syrup |
| Placebo | DRUG | Placebo to match MK-2828 oral capsule, taken once per day for 28 days. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is in good health * Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of clinically signifi...
MK-2828 is an investigational small molecule being developed by Merck & Company, Inc. (MRK) for chronic kidney failure, end-stage renal disease, renal impairment, and type 2 diabetes. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
MK-2828 is a small molecule in the nephrology therapeutic area. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not publicly detailed.
MK-2828 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK on the New York Stock Exchange. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics.
MK-2828 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. Multiple Phase 1 trials are being conducted to assess its safety, tolerability, and drug interactions in various patient populations.
MK-2828 has four Phase 1 trials: NCT07089784 (multiple dose study in type 2 diabetes, completed), NCT07348237 (kidney disease study, recruiting), NCT07431866 (drug interaction study with rosuvastatin or furosemide, completed), and NCT07435194 (interaction study with itraconazole and midazolam, active but not recruiting).
No alternative names for MK-2828 have been disclosed. It is identified solely by its code name MK-2828 in clinical trial registrations and company communications.