| Primary | Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to Infinity (AUC0-inf) | 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). | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups | | OG003 | Part 1: Severe Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG004 | Part 1: Healthy Participants (Severe RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000104(87.2 to 125)
- OG001141(115 to 174)
- OG00283.5(75.0 to 92.9)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Geometric Least Squares Mean Ratio (GMR) | 1.25 | | | 2-Sided | 90 | 1.07 | 1.47 | | | GMR is ratio of Experimental Group / Healthy Group | | Other | | | | | | |
|
| Primary | Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to the Time of the Last Quantifiable Sample (AUC0-last) | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups |
|
| Primary | Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to 24 Hours After Dosing (AUC0-24) | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours after dosing on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups |
|
| Primary | Part 1: Plasma Concentration of MK-3866 at the End of the Infusion (Ceoi) | Plasma samples were collected at pre-specified time points and Ceoi was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM | | At the end of the infusion (0.5 hours after infusion start) on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups | | OG003 |
|
| Primary | Part 1: Maximum Plasma Concentration of MK-3866 (Cmax) | Plasma samples were collected at pre-specified time points and Cmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the combined comparator experimental groups. | Posted | | Mean | 95% Confidence Interval | µM | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Severe Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG003 | Part 1: Healthy Participants (Mild, Moderate, and Severe RI) |
|
| Primary | Part 1: Plasma Clearance of MK-3866 (CL) | Plasma samples were collected at pre-specified time points and CL was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | L/hr | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups |
|
| Primary | Part 1: Time to Maximum Plasma Concentration of MK-3866 (Tmax) | Plasma samples were collected at pre-specified time points and Tmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Median | Full Range | Hours | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups |
|
| Primary | Part 1: Elimination Terminal Half-life of Plasma MK-3866 (t1/2) | 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). | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups |
|
| Primary | Part 1: Volume of Distribution of Plasma MK-3866 (Vz) | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups |
|
| Primary | Part 2: AUC0-inf of Plasma MK-3866 | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 | Part 1: Healthy Participants (ESRD) |
|
| Primary | Part 2: AUC0-last of Plasma MK-3866 | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 | Part 1: Healthy Participants (ESRD) |
|
| Primary | Part 2: AUC0-24 of Plasma MK-3866 | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM*hr | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 | Part 1: Healthy Participants (ESRD) |
|
| Primary | Part 2: Ceoi of Plasma MK-3866 | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM | | At the end of the infusion (0.5 hours after infusion start) on Day 1 of Period 1 and Period 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 | Part 1: Healthy Participants (ESRD) | |
|
| Primary | Part 2: Cmax of Plasma MK-3866 | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | µM | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 | Part 1: Healthy Participants (ESRD) |
|
| Primary | Part 2: CL of Plasma MK-3866 | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Mean | 95% Confidence Interval | L/hr | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 | Part 1: Healthy Participants (ESRD) |
|
| Primary | Part 2: Tmax of Plasma MK-3866 | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Median | Full Range | Hours | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 | Part 1: Healthy Participants (ESRD) |
|
| Primary | Part 2: t1/2 of Plasma MK-3866 | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 |
|
| Primary | Part 2: Vz of Plasma MK-3866 | 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. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 |
|
| Secondary | Part 1: Total Amount of MK-3866 Excreted in the Urine Over 24 Hours (Ae0-24) | Urine samples were collected at pre-specified intervals and Ae0-24 was assessed. Ae0-24 was obtained by adding the amounts excreted over each collection interval. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | mg | | Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups |
|
| Secondary | Part 1: Renal Clearance (CLr) of MK-3866 | Urine samples were collected at pre-specified intervals and CLr was assessed. CLr was calculated as AE(t'-t")/AUC(t'-t"), where t'-t" is the longest interval of time during which AE and AUC are both obtained. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | L/hr | | Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups |
|
| Secondary | Part 1: Fraction of MK-3866 Excretion (Urine) During Each Collection Interval (Fe0-24) | Urine samples were collected at pre-specified intervals and Fe0-24 was assessed. Fe0-24 was obtained by dividing the amount of MK-3866 excreted in each collection interval by the dose. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | Fraction of MK-3866 Excreted | | Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 | Part 1: Healthy Participants (Mild + Moderate RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups |
|
| Secondary | Part 2: Total Amount of MK-3866 Excreted Unchanged in the Urine Over the Period of 24 Hours (Ae0-24) | Urine samples were collected at pre-specified intervals and Ae0-24 was assessed. Ae0-24 was obtained by adding the amounts excreted over each collection interval. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg | | Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 | Part 1: Healthy Participants (ESRD) |
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| Secondary | Part 2: Renal Clearance (CLr) of MK-3866 | Urine samples were collected at pre-specified intervals and CLr was assessed. CLr was calculated as AE(t'-t")/AUC(t'-t"), where t'-t" is the longest interval of time during which AE and AUC are both obtained. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 | Part 1: Healthy Participants (ESRD) |
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| Secondary | Part 2: Fraction of MK-3866 Excretion (Urine) During Each Collection Interval (Fe0-24) | Urine samples were collected at pre-specified intervals and Fe0-24 was assessed. Fe0-24 was obtained by dividing the amount of MK-3866 excreted in each collection interval by the dose. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Fraction of MK-3866 Excreted | | Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 1: ESRD Undergoing HD (Dosed After HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2. | | OG001 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. | | OG002 | Part 1: Healthy Participants (ESRD) |
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| Secondary | Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca) | Plasma samples entering the dialyzer line were collected at pre-specified time points and Ca was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | µM | | 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv) | Plasma samples exiting the dialyzer line were collected at pre-specified time points and Cv was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | µM | | 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line During the Dialysis Period (AUCD) | Plasma samples entering the dialyzer line were collected at pre-specified time points and AUCD was assessed. AUCD values were determined from the Ca versus time profile during the HD period, using the 'linear up, log down' calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | µM*hr | | 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line From 0.75 to 4.5 Hours During the Dialysis Period (AUC[0.75-4.5]Ca) | Plasma samples entering the dialyzer line were collected at pre-specified time points and AUC[0.75-4.5]Ca was assessed. AUC[0.75-4.5]Ca values were determined from the Ca versus time profile from 0.75 to 4.5 hours during the HD period, using the 'linear up, log down' calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | µM*hr | | 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line From 0.75 to 4.5 Hours During the Dialysis Period (AUC[0.75-4.5]Cv) | Plasma samples entering the dialyzer line were collected at pre-specified time points and AUC[0.75-4.5]Cv was assessed. AUC[0.75-4.5]Cv values were determined from the Cv versus time profile from 0.75 to 4.5 hours during the HD period, using the 'linear up, log down' calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | µM*hr | | 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Part 2: Dialysis Clearance of MK-3866 Based on Plasma (CLD,Plasma) | Plasma dialysis samples were collected at pre-specified time points and CLD was assessed. CLD was calculated as Q x R x (AUC[1-4.5]Ca - AUC[1-4.5]Cv) / AUC[1-4.5]Ca, where Q is the flow rate of blood through the dialyzer, and R is the ratio of blood drug concentration to plasma drug concentration. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Part 2: Concentration of MK-3866 in Dialysate Samples (CD) | Plasma dialysis samples were collected at pre-specified time points and CD was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Mean | Standard Deviation | µM | | 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD) | Plasma dialysis samples were collected at pre-specified time points and AD was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg | | 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Part 2: Rate of Removal of MK-3866 From the Dialysate (rr) | Plasma dialysis samples were collected at pre-specified time points and rr was assessed. rr was calculated as CD x dialysate flow rate. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg/hr | | 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Part 2: Cumulative Amount of MK-3866 Recovered From the Dialysate (AD,Total) | Plasma dialysis samples were collected at pre-specified time points and AD,total was assessed. AD,total was obtained by integrating the rr versus time profile over the dialysis session duration, using actual times relative to the start time of dialysis. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mg | | 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Part 2: Hemodialysis Clearance of MK-3866 Based on the Dialysate(CLD,Dialysate) | Plasma dialysis samples were collected at pre-specified time points and CLD,dialysate was assessed. CLD,dialysate was calculated as AD.total / AUCD. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV. | All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2). | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2 | | | | ID | Title | Description |
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| OG000 | Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD) | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2. |
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| Secondary | Number of Participants With at Least One Adverse Event (AE) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Count of Participants | | Participants | | Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing | | | | ID | Title | Description |
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| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 |
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| Secondary | Number of Participants Discontinuing the Study Due to an Adverse Event | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s). | Posted | | Count of Participants | | Participants | | Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing | | | | ID | Title | Description |
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| OG000 | Part 1: Mild Renal Impairment (RI) | Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG001 | Part 1: Moderate Renal Impairment | Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. | | OG002 |
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