Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-5684 · 2 trials · 6 indications
Blood samples will be collected to determine the AUC0-inf of MK-5684 in plasma.
Blood samples will be collected to determine the AUC0-last of MK-5684 in plasma.
Blood samples will be collected to determine the AUC0-24 of MK-5684 in plasma.
Blood samples will be collected to determine the Cmax of MK-5684 in plasma.
Blood samples will be collected to determine the Tmax of MK-5684 in plasma.
Blood samples will be collected to determine the t1/2 of MK-5684 in plasma.
Blood samples will be collected to determine the CL/F of MK-5684 in plasma.
Blood samples will be collected to determine the Vz/F of MK-5684 in plasma.
AUC0-inf of MK-5684 in plasma will be determined.
AUC0-last of MK-5684 in plasma will be determined.
AUC0-24 of MK-5684 in plasma will be determined.
Cmax of MK-5684 in plasma will be determined.
Tmax of MK-5684 in plasma will be determined.
t1/2 of MK-5684 in plasma will be determined.
CL/F of MK-5684 in plasma will be determined.
Vz/F of MK-5684 in plasma will be determined.
| Arm | Type | Description |
|---|---|---|
| Group 1: Severe Renal Impairment (RI) | EXPERIMENTAL | Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal). |
| Group 2: End-stage renal disease (ESRD) | EXPERIMENTAL | Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) in Period 1 and Period 2. In Period 1, participants will receive a single oral dose of MK-5684 approximately 30 minutes prior to their normally scheduled hemodialysis (HD), followed by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing. In Period 2, participants will receive a single oral dose of MK-5684 immediately followed by completion of their normally scheduled HD, and by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing. |
| Group 3: Healthy Participants | EXPERIMENTAL | Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal). |
| MK-5684 Period 1 | EXPERIMENTAL | On Day 1 a single dose of MK-5684 will be administered under fasting conditions and a single dose of HRT (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after MK-5684 dosing. |
| MK-5684 Period 2 | EXPERIMENTAL | There will be a washout of at least 5 days between MK-5684 dosing in Period 1 and the first diltiazem dosing in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 6 consecutive days with a single dose of MK-5684 coadministered on Day 2 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 2 through 5, approximately 4.5 hours after MK-5684 and/or diltiazem dosing. |
| Name | Type | Description |
|---|---|---|
| MK-5684 | DRUG | Oral tablet |
| Prednisone | DRUG | Oral tablet |
| Fludrocortisone acetate | DRUG | Oral tablet |
| Diltiazem hydrocholoride | DRUG | Administered at a dose of 240 mg per dosing regimen via oral capsule (extended-release). |
Inclusion Criteria: Inclusion criteria include, but are not limited to: All Participants * Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to the first dosing * Has a body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m\^2 at the screening...
MK-5684 is an investigational small molecule being studied for use in prostatic neoplasms and chronic kidney failure. It is in Phase 1 clinical development by Merck & Company, Inc. (MRK). The drug is not approved and remains under investigation in clinical trials.
MK-5684 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers and patients with certain conditions.
MK-5684 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 studies have been completed, both involving male participants, to assess drug interactions and the effects of renal impairment.
MK-5684 has been studied in two completed Phase 1 trials. NCT06554639 evaluated a drug-drug interaction with diltiazem in healthy adult males. NCT06814132 assessed the effect of MK-5684 in males with severe renal impairment or end-stage renal disease. Both trials were conducted in the United States.
MK-5684 is the primary name used in clinical trials. No alternative names have been reported for this investigational drug. It is being studied under this identifier by Merck & Company, Inc. in ongoing research.