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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4031-350 | Other Identifier | Merck protocol number |
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This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Participants | Active Comparator | Participants with normal renal function defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
|
| Participants with Moderate Renal Impairment | Experimental | Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
|
| Participants with Severe Renal Impairment | Experimental | Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIFN-2b (Sylatron®) | Drug | Single 4.5 μg/kg dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose. | From hour 0 (pre-dose) to 288 hours post-dose |
| AUC From Time 0 to the Last Measurable Sample (AUC0-last) | AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample. | From hour 0 (pre-dose) up to 288 hours post-dose |
| Maximum Observed Serum Concentration (Cmax) | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. | From hour 0 (pre-dose) to 288 hours post-dose |
| Time to Maximum Observed Serum Concentration (Tmax) | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. | From hour 0 (pre-dose) up to 288 hours post-dose |
| Apparent Terminal Half-life (T1/2) | T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. | From hour 0 (pre-dose) up to 288 hours post-dose |
| Apparent Total Body Clearance (CL/F) | CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). | From hour 0 (pre-dose) up to 288 hours post-dose |
| Apparent Volume of Distribution (Vd/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants | Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| FG001 | Participants With Moderate Renal Impairment | Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| FG002 | Participants With Severe Renal Impairment | Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Participants | Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| BG001 | Participants With Moderate Renal Impairment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose. | All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm. | Posted | Least Squares Mean | 95% Confidence Interval | pg*hr/mL | From hour 0 (pre-dose) to 288 hours post-dose |
|
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One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Participants | Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
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|
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. |
| From hour 0 (pre-dose) up to 288 hours post-dose |
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| BG002 | Participants With Severe Renal Impairment | Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
| OG002 | Participants With Severe Renal Impairment | Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
|
|
| Primary | AUC From Time 0 to the Last Measurable Sample (AUC0-last) | AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample. | All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm. | Posted | Least Squares Mean | 95% Confidence Interval | pg*hr/mL | From hour 0 (pre-dose) up to 288 hours post-dose |
|
|
|
| Primary | Maximum Observed Serum Concentration (Cmax) | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. | All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm. | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | From hour 0 (pre-dose) to 288 hours post-dose |
|
|
|
| Primary | Time to Maximum Observed Serum Concentration (Tmax) | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. | All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm. | Posted | Median | 95% Confidence Interval | hours | From hour 0 (pre-dose) up to 288 hours post-dose |
|
|
|
| Primary | Apparent Terminal Half-life (T1/2) | T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. | All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | From hour 0 (pre-dose) up to 288 hours post-dose |
|
|
|
| Primary | Apparent Total Body Clearance (CL/F) | CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). | All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm. | Posted | Number | 95% Confidence Interval | mL/min | From hour 0 (pre-dose) up to 288 hours post-dose |
|
|
|
| Primary | Apparent Volume of Distribution (Vd/F) | Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. | All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm. | Posted | Geometric Mean | 95% Confidence Interval | Liters | From hour 0 (pre-dose) up to 288 hours post-dose |
|
|
|
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | Participants With Moderate Renal Impairment | Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. | 0 | 7 | 7 | 7 |
| EG002 | Participants With Severe Renal Impairment | Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. | 1 | 6 | 6 | 6 |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Lymph node palpable | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Hypogeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Thirst | General disorders | MedDRA 15.0 | Systematic Assessment |
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The Investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the Sponsor. The Investigator further agrees to provide review copies of abstracts or manuscripts for publication that report any results of the trial to the Sponsor 45 days prior to submission for publication or presentation. The Sponsor shall have the right to review and comment.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |