Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-3866 · 1 trial · 1 indication
Plasma samples were collected at pre-specified time points and AUC0-inf was assessed. Plasma concentrations of MK-3866 were determined using high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS).
Plasma samples were collected at pre-specified time points and AUC0-last was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Plasma samples were collected at pre-specified time points and AUC0-24 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Plasma samples were collected at pre-specified time points and Ceoi was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Plasma samples were collected at pre-specified time points and Cmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Plasma samples were collected at pre-specified time points and CL was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Plasma samples were collected at pre-specified time points and Tmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Plasma samples were collected at pre-specified time points and t1/2 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric % coefficient of variation (%CV).
Plasma samples were collected at pre-specified time points and Vz was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Plasma samples were collected at pre-specified time points and AUC0-inf was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Plasma samples were collected at pre-specified time points and AUC0-last was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Plasma samples were collected at pre-specified time points and AUC0-24 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Plasma samples were collected at pre-specified time points and Ceoi was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Plasma samples were collected at pre-specified time points and Cmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Plasma samples were collected at pre-specified time points and CL was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Plasma samples were collected at pre-specified time points and Tmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Plasma samples were collected at pre-specified time points and t1/2 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1. Method of dispersion used for these data is geometric %CV.
Plasma samples were collected at pre-specified time points and Vz was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1. Method of dispersion used for these data is geometric %CV.
| Arm | Type | Description |
|---|---|---|
| Part 1: Mild Renal Impairment | EXPERIMENTAL | Participants receive a single IV infusion of 200 mg MK-3866 over 30 minutes on Day 1. |
| Part 1: Moderate Renal Impairment | EXPERIMENTAL | Participants receive a single IV infusion of 200 mg MK-3866 over 30 minutes on Day 1. |
| Part 1: Severe Renal Impairment | EXPERIMENTAL | Participants receive a single IV infusion of 200 mg MK-3866 over 30 minutes on Day 1. |
| Part 1: Healthy Participants | EXPERIMENTAL | Participants receive a single IV infusion of 200 mg MK-3866 over 30 minutes on Day 1. |
| Part 2: End-stage Renal Disease Undergoing Hemodialysis | EXPERIMENTAL | End-stage renal disease (ESRD) participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after hemodialysis (HD) in Period 1 and just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
| Name | Type | Description |
|---|---|---|
| MK-3866 | DRUG | Single IV infusion of 200 mg administered over 30 minutes (±5 minutes) on Day 1 of each treatment period. |
Inclusion Criteria: * Females of non-childbearing potential. Male participants with female partner(s) of child-bearing potential agree to use a medically acceptable method of contraception during the study and for 90 days after dosing. If partner is pregnant, males agree to use a condom; if partner...
MK-3866 is an investigational small molecule being studied for use in renal impairment. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development. The drug is intended for patients with impaired renal function, and its safety and pharmacokinetics are being evaluated in this population.
MK-3866 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its pharmacokinetics and safety in patients with renal impairment, but the mechanism of action has not been publicly detailed. As such, the target of MK-3866 remains unknown.
MK-3866 is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with renal impairment.
MK-3866 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its safety and pharmacokinetics in patients with renal impairment, and it is not yet available for commercial use.
MK-3866 has one completed Phase 1 clinical trial, identified as NCT03259087. This trial, titled "Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)," enrolled 42 participants in the United States. The study evaluated the drug's safety and pharmacokinetics in individuals with renal impairment and healthy controls.
MK-3866 is a unique investigational drug developed by Merck & Company, Inc. There are no alternative names provided for this compound. It is being studied under its own identifier and is not known to be the same as any other marketed or investigational drug.