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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6482-021 | Other Identifier | MSD |
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The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD) to each other and also to that of healthy matched control participants. This study will also evaluate the safety and tolerability of a single oral 120 mg dose of belzutifan in participants with ESRD and the extent of belzutifan removed by HD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belzutifan in Participants with ESRD | Experimental | In period 1, participants with ESRD will receive a single, oral dose of belzutifan 120 mg on Day 1 after HD. In period 2, participants with ESRD will receive a single, oral dose of belzutifan 120 mg on Day 1 before HD. Each period is 4 days. |
|
| Belzutifan in Healthy Participants | Experimental | In period 1, healthy participants will receive a single, oral dose of belzutifan 120 mg on Day 1 of a 4-day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belzutifan | Drug | Three 40 mg tablets given as a single oral 120 mg dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to Infinity (AUC0-inf) | AUC0-inf was defined as the area under the concentration-time curve of belzutifan from time zero to infinity. Blood samples collected predose and at multiple timepoints postdose were used to determine AUC0-inf of belzutifan in plasma. | Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose |
| Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to 24 (AUC0-24) | AUC0-24 was defined as the area under the concentration-time curve of belzutifan from time zero to 24 hours postdose. Blood samples collected predose and at multiple timepoints postdose were used to determine AUC0-24 of belzutifan in plasma. | Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, and 24 hours postdose |
| Maximum Plasma Concentration (Cmax) of Belzutifan | Cmax is the maximum concentration of belzutifan observed in plasma. Blood samples collected predose and at multiple timepoints postdose were used to determine Cmax of belzutifan in plasma. | Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose |
| Time to Maximum Plasma Concentration (Tmax) of Belzutifan | Tmax is the amount of time that belzutifan is present at the maximum concentration observed in plasma. Blood samples collected predose and at multiple timepoints postdose were used to determine Tmax of belzutifan in plasma. | Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose |
| Apparent Terminal Half-life (t½) of Plasma Belzutifan | t1/2 is defined as the time required to divide plasma concentration of belzutifan by half. Blood samples collected predose and at multiple timepoints postdose were used to determine the apparent terminal t1/2 of belzutifan in plasma. |
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis Clearance of Belzutifan Based on Plasma (CLD, Plasma) | CLD, plasma is defined as a measure of the extent of belzutifan removed by HD. Blood samples collected at pre-dialysis and at multiple timepoints post-dialysis were used to measure the extent of belzutifan in plasma removal by HD. | Pre-dialysis, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours post-dialysis on Day 1 of Period 2 (Study Day ~12) |
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Inclusion Criteria:
For Participants With Healthy Renal Function
For Participants With end stage renal disease (ESRD)
Exclusion Criteria:
For Participants With Healthy Renal Function
Participants With ESRD
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center ( Site 0001) | Orlando | Florida | 32809 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Participants with end stage renal diseases (ESRD) and healthy matched control participants were recruited at a single study site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belzutifan in Participants With ESRD | In period 1, participants with ESRD received a single, oral dose of belzutifan 120 mg on Day 1 after hemodialysis (HD). In period 2, participants with ESRD received a single, oral dose of belzutifan 120 mg on Day 1 before HD. Each period is 4 days. |
| FG001 | Belzutifan in Healthy Participants | In period 1, healthy participants received a single, oral dose of belzutifan 120 mg on Day 1 of a 4-day period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Belzutifan in Participants With ESRD | In period 1, participants with ESRD received a single, oral dose of belzutifan 120 mg on Day 1 after HD. In period 2, participants with ESRD received a single, oral dose of belzutifan 120 mg on Day 1 before HD. Each period is 4 days. |
| BG001 | Belzutifan in Healthy Participants |
| 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 Plasma Concentration Time Curve of Belzutifan From Hour 0 to Infinity (AUC0-inf) | AUC0-inf was defined as the area under the concentration-time curve of belzutifan from time zero to infinity. Blood samples collected predose and at multiple timepoints postdose were used to determine AUC0-inf of belzutifan in plasma. | All participants who are compliant with the study procedure and have available data considered sufficient to exhibit the effect of treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng•hr/mL | Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose |
|
Up to 32 days.
All-Cause Mortality is reported for all allocated participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. All adverse events that occurred after dosing are summarized. Every participant is counted a single time for each applicable adverse event.
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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 | Belzutifan in Participants With ESRD Before HD (Period 2) | In period 1, participants with ESRD received a single, oral dose of belzutifan 120 mg on Day 1 after HD. In period 2, participants with ESRD received a single, oral dose of belzutifan 120 mg on Day 1 before HD. Each period is 4 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2023 | Mar 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C000720612 | belzutifan |
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| Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose |
| Percentage of Participants Who Experienced an Adverse Event (AE) | An AE is 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. The percentage of participants who experienced an AE are reported. | Up to 32 days |
| Percentage of Participants Who Discontinue Study Intervention Due to an AE | An AE is 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. The percentage of participants who discontinue study intervention due to an AE are reported. | Up to 12 days |
| NOT COMPLETED |
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In period 1, healthy participants received a single, oral dose of belzutifan 120 mg on Day 1 of a 4-day period. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Belzutifan in ESRD After HD (Period 1) | In period 1, participants with ESRD received a single, oral dose of belzutifan 120 mg on Day 1 after HD. In period 2, participants with ESRD received a single, oral dose of belzutifan 120 mg on Day 1 before HD. Each period is 4 days. |
| OG002 | Belzutifan in Healthy Participants | In period 1, healthy participants received a single, oral dose of belzutifan 120 mg on Day 1 of a 4-day period. |
|
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| Primary | Area Under the Plasma Concentration Time Curve of Belzutifan From Hour 0 to 24 (AUC0-24) | AUC0-24 was defined as the area under the concentration-time curve of belzutifan from time zero to 24 hours postdose. Blood samples collected predose and at multiple timepoints postdose were used to determine AUC0-24 of belzutifan in plasma. | All participants who are compliant with the study procedure and have available data considered sufficient to exhibit the effect of treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng•hr/mL | Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, and 24 hours postdose |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Belzutifan | Cmax is the maximum concentration of belzutifan observed in plasma. Blood samples collected predose and at multiple timepoints postdose were used to determine Cmax of belzutifan in plasma. | All participants who are compliant with the study procedure and have available data considered sufficient to exhibit the effect of treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose |
|
|
|
| Primary | Time to Maximum Plasma Concentration (Tmax) of Belzutifan | Tmax is the amount of time that belzutifan is present at the maximum concentration observed in plasma. Blood samples collected predose and at multiple timepoints postdose were used to determine Tmax of belzutifan in plasma. | All participants who are compliant with the study procedure and have available data considered sufficient to exhibit the effect of treatment. | Posted | Median | Full Range | hour | Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose |
|
|
|
| Primary | Apparent Terminal Half-life (t½) of Plasma Belzutifan | t1/2 is defined as the time required to divide plasma concentration of belzutifan by half. Blood samples collected predose and at multiple timepoints postdose were used to determine the apparent terminal t1/2 of belzutifan in plasma. | All participants who are compliant with the study procedure and have available data considered sufficient to exhibit the effect of treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Predose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 72 hours postdose |
|
|
|
| Secondary | Dialysis Clearance of Belzutifan Based on Plasma (CLD, Plasma) | CLD, plasma is defined as a measure of the extent of belzutifan removed by HD. Blood samples collected at pre-dialysis and at multiple timepoints post-dialysis were used to measure the extent of belzutifan in plasma removal by HD. | Per protocol, CLD was measured in participants with ESRD who were treated with belzutifan before HD (Period 2). Participants in period 2 who are compliant with the study procedure and have available data considered sufficient to exhibit the effect of treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | Pre-dialysis, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours post-dialysis on Day 1 of Period 2 (Study Day ~12) |
|
|
|
| Secondary | Percentage of Participants Who Experienced an Adverse Event (AE) | An AE is 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. The percentage of participants who experienced an AE are reported. | All participants who received at least one dose of study intervention. | Posted | Number | Percentage of Participants | Up to 32 days |
|
|
|
| Secondary | Percentage of Participants Who Discontinue Study Intervention Due to an AE | An AE is 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. The percentage of participants who discontinue study intervention due to an AE are reported. | All participants who received at least one dose of study intervention. | Posted | Number | Percentage of Participants | Up to 12 days |
|
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| 0 |
| 7 |
| EG001 | Belzutifan in Participants With ESRD After HD (Period 2) | In period 1, participants with ESRD received a single, oral dose of belzutifan 120 mg on Day 1 after HD. In period 2, participants with ESRD received a single, oral dose of belzutifan 120 mg on Day 1 before HD. Each period is 4 days. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Belzutifan in Healthy Participants | In period 1, healthy participants received a single, oral dose of belzutifan 120 mg on Day 1 of a 4-day period. | 0 | 6 | 0 | 6 | 1 | 6 |
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |