Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-3682B · 1 trial · 1 indication
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 |
MK-3682B is an investigational small molecule being developed for the treatment of Hepatitis C. It is currently in Phase 1 clinical development. The drug is being studied in patients with moderate to severe renal insufficiency, as well as in healthy volunteers, to evaluate its pharmacokinetics.
MK-3682B is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in participants with Hepatitis C.
MK-3682B is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, which enrolled 16 participants to study the drug's pharmacokinetics in individuals with moderate to severe renal insufficiency.
MK-3682B has one completed clinical trial, NCT02661126, titled "Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030)." This Phase 1 study enrolled 16 participants, including healthy volunteers, and was a controlled trial that did not use randomization or blinding.
MK-3682B is a distinct investigational drug candidate. No alternative names have been reported for this compound. It is being studied specifically for its pharmacokinetic profile in patients with renal impairment and Hepatitis C, and it is not known to be identical to any other marketed medication.