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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02661126 | Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030) | PHASE1 | COMPLETED | 16 | — | — | Jan 19, 2016 | Aug 26, 2016 | Jan 9, 2019 | - | — |
AUC0-last is a measure of total exposure to uprifosbuvir in plasma from the start of dosing to the time of the last quantifiable (\< lower limit of quantification \[LLOQ\]) sample following oral administration of MK-3682B.
AUC0-∞ is a measure of total exposure to uprifosbuvir in plasma from the start of dosing to infinity following oral administration of MK-3682B.
AUC0-24 is a measure of total exposure to uprifosbuvir in plasma from dosing to 24 hours following oral administration of MK-3682B.
Cmax is the maximum amount of uprifosbuvir in plasma following oral administration of MK-3682B.
C24 is the plasma concentration of uprifosbuvir 24 hours following oral administration of MK-3682B.
Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir following oral administration of MK-3682B.
CL/F is the apparent total body clearance of uprifosbuvir following oral administration of MK-3682B.
Vz/F is the apparent volume of distribution of uprifosbuvir following oral administration of MK-3682B.
t1/2 is the amount of time required to clear 50% of uprifosbuvir from plasma following oral administration of MK-3682B.
AUC0-last is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.
AUC0-∞ is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from the start of dosing to infinity following oral administration of MK-3682B.
AUC0-24 is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from dosing to 24 hours following oral administration of MK-3682B.
Cmax is the maximum amount of uprifosbuvir metabolite M5 in plasma following oral administration of MK-3682B.
C24 is the plasma concentration of uprifosbuvir metabolite M5 24 hours following oral administration of MK-3682B.
Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir metabolite M5 following oral administration of MK-3682B.
Tlag is the time from dosing to first appearance in plasma of uprifosbuvir metabolite M5 following oral administration of MK-3682B.
t1/2 is the amount of time required to clear 50% of uprifosbuvir metabolite M5 from plasma following oral administration of MK-3682B.
AUC0-last is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.
AUC0-∞ is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from the start of dosing to infinity following oral administration of MK-3682B.
AUC0-24 is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from dosing to 24 hours following oral administration of MK-3682B.
Cmax is the maximum amount of uprifosbuvir metabolite M6 in plasma following oral administration of MK-3682B.
C24 is the plasma concentration of uprifosbuvir metabolite M6 24 hours following oral administration of MK-3682B.
Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir metabolite M6 following oral administration of MK-3682B.
t1/2 is the amount of time required to clear 50% of uprifosbuvir metabolite M6 from plasma following oral administration of MK-3682B.
AUC0-last is a measure of total exposure to grazoprevir in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.
AUC0-∞ is a measure of total exposure to grazoprevir in plasma from the start of dosing to infinity following oral administration of MK-3682B.
AUC0-24 is a measure of total exposure to grazoprevir in plasma from the start of dosing to 24 hours post-dose following oral administration of MK-3682B.
Cmax is the maximum amount of grazoprevir in plasma following oral administration of MK-3682B.
C24 is the plasma concentration of grazoprevir 24 hours following oral administration of MK-3682B.
Tmax is the time required to reach the maximum post-dose plasma concentration of grazoprevir following oral administration of MK-3682B.
CL/F is the apparent total body clearance of grazoprevir following oral administration of MK-3682B.
Vz/F is the apparent volume of distribution of grazoprevir following oral administration of MK-3682B.
t1/2 is the amount of time required to clear 50% of grazoprevir from plasma following oral administration of MK-3682B.
AUC0-last is a measure of total exposure to ruzasvir in plasma from the start of dosing to the time of the last quantifiable (\<LLOQ) sample following oral administration of MK-3682B.
AUC0-∞ is a measure of total exposure to ruzasvir in plasma from the start of dosing to infinity following oral administration of MK-3682B.
AUC0-24 is a measure of total exposure to ruzasvir in plasma from dosing to 24 hours following oral administration of MK-3682B.
Cmax is the maximum amount of ruzasvir in plasma following oral administration of MK-3682B.
C24 is the plasma concentration of ruzasvir 24 hours following oral administration of MK-3682B.
Tmax is the time required to reach the maximum post-dose plasma concentration of ruzasvir following oral administration of MK-3682B.
CL/F is the apparent total body clearance of ruzasvir following oral administration of MK-3682B.
Vz/F is the apparent volume of distribution of ruzasvir following oral administration of MK-3682B.
t1/2 is the amount of time required to clear 50% of ruzasvir from plasma following oral administration of MK-3682B.
| Arm | Type | Description |
|---|---|---|
| Moderate RI Participants | EXPERIMENTAL | Participants with an estimated glomerular filtration rate (eGFR) of ≥30 mL/min/1.73m\^2 to \<60 mL/min/1.73m\^2 take 2 MK-3682B FDC tablets on Day 1 after fasting for 10 hours. |
| Severe RI Participants | EXPERIMENTAL | Participants with an eGFR of ≥15 mL/min/1.73m\^2 to \<30 mL/min/1.73m\^2 take 2 MK-3682B FDC tablets on Day 1 after fasting for 10 hours. |
| Healthy Participants | EXPERIMENTAL | Healthy participants (creatinine clearance \[CLcr\] ≥80 mL/min) take 2 MK-362B FDC tablets on Day 1 after fasting for 10 hours. Healthy participants are matched to RI participants based on mean age, body mass index (BMI) and gender. |
| Name | Type | Description |
|---|---|---|
| MK-3682B | DRUG | FDC oral tablet containing 225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir. |
Inclusion Criteria: All Participants: * Healthy adult males or females 18-80 years of age at screening * Continuous non-smokers or moderate smokers (≤ 20 cigarettes/day or the equivalent) and agrees to consume no more than 10 cigarettes per day during the study period * BMI ≥ 18 and ≤ 40.0 kg/m\^2...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | — | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | — | Undisclosed |