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| ID | Type | Description | Link |
|---|---|---|---|
| MK-2060-012 | Other Identifier | Merck | |
| jRCT2041230025 | Registry Identifier | jRCT |
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The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal disease (ESRD) on dialysis. There is no primary hypothesis for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-2060 | Experimental | Participants receive MK-2060 50 mg via a single intravenous (IV) infusion over 60-minutes. |
|
| Placebo | Placebo Comparator | Participants receive a single IV saline infusion over 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2060 | Biological | Lyophilized powder diluted in normal saline for IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who experienced an AE is reported. | Up to approximately 164 days |
| Number of Participants Who Discontinued Study Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who discontinued study due to an AE is reported. | Up to approximately 164 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC 0-inf) | Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf is defined as the area under the concentration-time curve of MK-2060 from time zero to infinity. | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasugai Municipal Hospital ( Site 1203) | Kasugai | Aichi-ken | 486-8510 | Japan | ||
| Chubu Rosai Hospital ( Site 1202) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-2060 | Participants received MK-2060 50 mg via a single intravenous (IV) infusion over 60 minutes. |
| FG001 | Placebo | Participants received a single IV saline infusion over 60 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 9, 2022 |
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Double blind
| Placebo |
| Drug |
IV infusion |
|
|
| Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Last (AUC0-last) | Blood samples were collected at specified intervals for the determination of AUC0-last. AUC0-last is defined as the area under the plasma concentration-time curve from time zero to time of last measurable concentration of MK-2060. | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
| Area Under the Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours Postdose (AUC0-168) | Blood samples were collected at specified intervals for the determination of AUC0-168. AUC0-168 is defined as the area under the concentration-time curve of MK-2060 from time zero to 168 hours. | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
| Maximum Concentration (Cmax) of MK-2060 | Blood samples were collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-2060 reached. | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
| Concentration at 168 Hours (C168) Postdose of MK-2060 | Blood samples were collected at specified intervals for the determination of C168. C168 is defined as the maximum concentration of MK-2060 reached at 168 hours postdose. | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
| Time to Maximum Concentration (Tmax) of MK-2060 | Blood samples were collected at specified intervals for the determination of Tmax. Tmax is defined as time to the maximum concentration of MK-2060 reached. | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
| Time of the Last Measurable Plasma Concentration (Tlast) of MK-2060 | Blood samples were collected at specified intervals for the determination of Tlast. Tlast is defined as the time to the last measurable concentration of MK-2060 reached. | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
| Terminal Half-Life (t ½) of MK-2060 | Blood samples were collected at specified intervals for the determination of t½. t½ is defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-2060. | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
| Clearance (CL) of MK-2060 | Blood samples were collected at specified intervals for the determination of CL. CL is the volume of plasma from which the study drug is completely removed per unit time. | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
| Volume of Distribution (Vz) of MK-2060 | Blood samples were collected at specified intervals for the determination of Vz. Vz is the apparent volume of distribution during the terminal phase. | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
| Change From Baseline in Activated Partial Thromboplastin Time (aPTT) | Blood samples were collected for the determination of aPTT. Change from baseline in aPTT up to 168 hours post dose (pre dialysis) is reported. | Baseline and 168 hours post dose |
| Nagoya |
| Aichi-ken |
| 455-8530 |
| Japan |
| Kojunkai Daido Hospital ( Site 1207) | Nagoya | Aichi-ken | 457-8511 | Japan |
| Jomo Ohashi Clinic ( Site 1210) | Maebashi | Gunma | 371-0046 | Japan |
| Ibaraki Prefectural Central Hospital ( Site 1211) | Kasama | Ibaraki | 309-1793 | Japan |
| Shonan Kamakura General Hospital ( Site 1205) | Kamakura | Kanagawa | 247-8533 | Japan |
| Matsumoto City Hospital ( Site 1209) | Matsumoto | Nagano | 390-1401 | Japan |
| Keiaikai Nakamura Hospital ( Site 1213) | Beppu | Oita Prefecture | 874-0937 | Japan |
| Omi Fureai Hospital ( Site 1204) | Kusatsu | Shiga | 525-8585 | Japan |
| Ikegami General Hospital ( Site 1206) | Ōta-ku | Tokyo | 146-8531 | Japan |
| Japanese Red Cross Fukuoka Hospital ( Site 1214) | Fukuoka | 815-8555 | Japan |
| Yamagata Tokushukai Hospital ( Site 1201) | Yamagata | 990-0834 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-2060 | Participants received MK-2060 50 mg via a single intravenous (IV) infusion over 60 minutes. |
| BG001 | Placebo | Participants received a single IV saline infusion over 60 minutes. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Number of Participants Who Experienced an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who experienced an AE is reported. | All participants who received at least one dose of treatment. | Posted | Count of Participants | Participants | Up to approximately 164 days |
|
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| |||||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued Study Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who discontinued study due to an AE is reported. | All participants who received at least one dose of treatment | Posted | Count of Participants | Participants | Up to approximately 164 days |
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| ||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC 0-inf) | Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf is defined as the area under the concentration-time curve of MK-2060 from time zero to infinity. | All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nmol/L | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Last (AUC0-last) | Blood samples were collected at specified intervals for the determination of AUC0-last. AUC0-last is defined as the area under the plasma concentration-time curve from time zero to time of last measurable concentration of MK-2060. | All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nmol/L | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours Postdose (AUC0-168) | Blood samples were collected at specified intervals for the determination of AUC0-168. AUC0-168 is defined as the area under the concentration-time curve of MK-2060 from time zero to 168 hours. | All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nmol/L | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
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| Secondary | Maximum Concentration (Cmax) of MK-2060 | Blood samples were collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-2060 reached. | All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
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| Secondary | Concentration at 168 Hours (C168) Postdose of MK-2060 | Blood samples were collected at specified intervals for the determination of C168. C168 is defined as the maximum concentration of MK-2060 reached at 168 hours postdose. | All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
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| Secondary | Time to Maximum Concentration (Tmax) of MK-2060 | Blood samples were collected at specified intervals for the determination of Tmax. Tmax is defined as time to the maximum concentration of MK-2060 reached. | All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included. | Posted | Median | Full Range | hours | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
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| Secondary | Time of the Last Measurable Plasma Concentration (Tlast) of MK-2060 | Blood samples were collected at specified intervals for the determination of Tlast. Tlast is defined as the time to the last measurable concentration of MK-2060 reached. | All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included. | Posted | Median | Full Range | hours | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
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| Secondary | Terminal Half-Life (t ½) of MK-2060 | Blood samples were collected at specified intervals for the determination of t½. t½ is defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-2060. | All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Days | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
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| Secondary | Clearance (CL) of MK-2060 | Blood samples were collected at specified intervals for the determination of CL. CL is the volume of plasma from which the study drug is completely removed per unit time. | All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
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| Secondary | Volume of Distribution (Vz) of MK-2060 | Blood samples were collected at specified intervals for the determination of Vz. Vz is the apparent volume of distribution during the terminal phase. | All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis |
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| Secondary | Change From Baseline in Activated Partial Thromboplastin Time (aPTT) | Blood samples were collected for the determination of aPTT. Change from baseline in aPTT up to 168 hours post dose (pre dialysis) is reported. | All participants who were compliant with the study procedures and have available data from at least one treatment were included. | Posted | Geometric Mean | 95% Confidence Interval | Fold-Change from baseline | Baseline and 168 hours post dose |
|
|
Up to approximately 164 days
All participants who received at least one dose of treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-2060 50 mg | Participants received MK-2060 50 mg via a single intravenous (IV) infusion over 60 minutes. | 0 | 12 | 3 | 12 | 9 | 12 |
| EG001 | Placebo | Participants received a single IV saline infusion over 60 minutes. | 0 | 5 | 1 | 5 | 4 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Enteritis infectious | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Duodenitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Vaccination site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Bleeding time prolonged | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Occult blood positive | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Internal haemorrhage | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Jan 24, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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