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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01275170 | A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005) | PHASE1 | COMPLETED | 49 | — | — | Jan 28, 2011 | Mar 5, 2012 | Jun 11, 2020 | - | — |
AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity.
The CLD of MK-7655 was determined in ESRD/HD participants for 4.5 hours during HD. The formula for calculating CLD was: CLd = (1-Hct)\*QB\*\[(pre-dialyzer concentration - post-dialyzer concentration) / (pre-dialyzer concentration)\] where QB=350 mL/min and Hct=hematocrit.
The extraction coefficient of MK-7655 was determined in ESRD/HD participants for 4.5 hours during HD. The formula for calculating extraction coefficient was: Extraction Coefficient = ABS\[100\*(post-dialyzer concentration - pre-dialyzer concentration) / pre-dialyzer concentration\].
| Arm | Type | Description |
|---|---|---|
| Panel A Mild Renal Impairment | EXPERIMENTAL | Participants with an eGFR of \>50 to \<80 mL/min/1.73 m\^2 receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. |
| Panel B Healthy Participants | EXPERIMENTAL | A subset of healthy control participants were matched specifically to participants in Panel A and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. |
| Panel C Moderate Renal Impairment | EXPERIMENTAL | Participants with an eGFR of 30 to 50 mL/min/1.73 m\^2 receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. |
| Panel D Healthy Participants | EXPERIMENTAL | A subset of healthy control participants were matched specifically to participants in Panel C and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. |
| Panel E Severe Renal Impairment | EXPERIMENTAL | Participants with an eGFR \<30 mL/min/1.73 m\^2 receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg. |
| Panel F Healthy Participants | EXPERIMENTAL | A subset of healthy control participants were matched specifically to participants in Panel E and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg. |
| Panel G End Stage Renal Disease with Hemodialysis (ESRD/HD) | EXPERIMENTAL | Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2). In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg predialysis (Part 2, Period 1) and postdialysis (Part 2, Period 2). |
| Panel H Healthy Volunteers | EXPERIMENTAL | A subset of healthy control participants were matched specifically to participants in Panel G and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg. |
| Name | Type | Description |
|---|---|---|
| MK-7655 | DRUG | 125 mg intravenous (IV) over 30 minutes as a single dose |
| Imipenem + Cilastatin | DRUG | 250 mg IV over 30 minutes as a single dose |
| Caffeine | DRUG | Caffeine caplet, single 200 mg dose, orally |
| Midazolam | DRUG | Midazolam hcl syrup single 2.0 mg dose by mouth. |
| Omeprazole | DRUG | Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally |
Inclusion criteria * Participants of reproductive potential (male or female) must be willing to use contraception. * Body Mass Index (BMI) ≤40 kg/m\^2 * Weight \>60 kg at screening visit * No clinically significant abnormality on electrocardiogram (ECG) at screening visit and/or prior to administra...