Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06814132 | A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010) | PHASE1 | COMPLETED | 24 | — | — | Apr 7, 2025 | Oct 14, 2025 | Oct 23, 2025 | 2 | United States |
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.
| 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). |
| Name | Type | Description |
|---|---|---|
| MK-5684 | DRUG | Oral tablet |
| Prednisone | DRUG | Oral tablet |
| Fludrocortisone acetate | DRUG | Oral tablet |
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...