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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0518-851 | Other Identifier | Merck Protocol Number |
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This study is designed to evaluate safety, tolerability, and pharmacokinetics of a single 1200-mg dose of raltegravir (MK-0518, ISENTRESS®) in healthy Japanese male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir | Experimental | Participants will receive a single oral dose of raltegravir 1200 mg (600 mg tablet X 2) in a fasted state on Day 0 and will be followed up to 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | Raltegravir 600 mg tablet |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a study drug, whether or not considered related to the study drug. The number of participants with an AE was reported. | Up to Day 14 after dosing |
| Number of Participants Discontinued From the Study Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a study drug, whether or not considered related to the study drug. The number of participants discontinued from the study due to an AE was reported. | Up to Day 14 after dosing |
| Number of Participants With a Serious Adverse Event (SAE) | A SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly or birth defect, is another medically important event, is a new cancer, or is an overdose. The number of participants with an SAE was reported. | Up to Day 14 after dosing |
| Number of Participants With a Drug-related AE | The number of participants with a drug-related AE was reported. Causality was be determined by the investigator. | Up to Day 14 after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve Up to Infinity (AUC0-∞) of Plasma Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of plasma raltegravir was calculated based on natural log-transformed values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 0001) | Tokyo | 171-0014 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir | Participants received a single oral dose of raltegravir 1200 mg (600 mg tablet X 2) in a fasted state on Day 0 and were followed up to 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir | Participants received a single oral dose of raltegravir 1200 mg (600 mg tablet X 2) in a fasted state on Day 0 and were followed up to 2 weeks |
| 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 |
| 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 With an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a study drug, whether or not considered related to the study drug. The number of participants with an AE was reported. | All participants who received at least one dose of the study drug | Posted | Count of Participants | Participants | Up to Day 14 after dosing |
|
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Up to 14 days after treatment with study drug
All participants who received at least one dose of the study drug.
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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 | Raltegravir | Participants received a single oral dose of raltegravir 1200 mg (600 mg tablet X 2) in a fasted state on Day 0 and were followed up to 2 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.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 | Jul 10, 2018 | Sep 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
| Maximum Plasma Concentration (Cmax) of Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. Maximum plasma concentration (Cmax) of raltegravir was calculated based on natural log-transformed values. | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
| Plasma Concentration of Raltegravir at 24 Hours After Dosing (C24) | Blood samples were collected at 24 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The plasma concentration of raltegravir at 24 hours after dosing (C24) was calculated based on natural log-transformed values. | 24 hours after dosing |
| Time of Maximum Plasma Concentration (Tmax) of Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The time at which Cmax of plasma raltegravir is achieved (Tmax) was reported. | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
| Apparent Plasma Half-life (t1/2) of Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent plasma half-life (t1/2) of raltegravir was reported. | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
| Apparent Total Plasma Clearance (CL/F) of Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent total plasma clearance of raltegravir after oral dosing (CL/F) was reported. | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
| Apparent Volume of Distribution (Vz/F) of Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent volume of distribution of raltegravir during the terminal phase (Vz/F) was reported. | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Number of Participants Discontinued From the Study Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a study drug, whether or not considered related to the study drug. The number of participants discontinued from the study due to an AE was reported. | All participants who received at least one dose of the study drug | Posted | Count of Participants | Participants | Up to Day 14 after dosing |
|
|
|
| Primary | Number of Participants With a Serious Adverse Event (SAE) | A SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly or birth defect, is another medically important event, is a new cancer, or is an overdose. The number of participants with an SAE was reported. | All participants who received at least one dose of the study drug | Posted | Count of Participants | Participants | Up to Day 14 after dosing |
|
|
|
| Primary | Number of Participants With a Drug-related AE | The number of participants with a drug-related AE was reported. Causality was be determined by the investigator. | All participants who received at least one dose of the study drug | Posted | Count of Participants | Participants | Up to Day 14 after dosing |
|
|
|
| Secondary | Area Under the Concentration-Time Curve Up to Infinity (AUC0-∞) of Plasma Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of plasma raltegravir was calculated based on natural log-transformed values. | Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | (μM•hr) | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. Maximum plasma concentration (Cmax) of raltegravir was calculated based on natural log-transformed values. | Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | nM | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
|
|
|
| Secondary | Plasma Concentration of Raltegravir at 24 Hours After Dosing (C24) | Blood samples were collected at 24 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The plasma concentration of raltegravir at 24 hours after dosing (C24) was calculated based on natural log-transformed values. | Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | nM | 24 hours after dosing |
|
|
|
| Secondary | Time of Maximum Plasma Concentration (Tmax) of Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The time at which Cmax of plasma raltegravir is achieved (Tmax) was reported. | Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations. | Posted | Median | Full Range | Hours | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
|
|
|
| Secondary | Apparent Plasma Half-life (t1/2) of Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent plasma half-life (t1/2) of raltegravir was reported. | Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
|
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| Secondary | Apparent Total Plasma Clearance (CL/F) of Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent total plasma clearance of raltegravir after oral dosing (CL/F) was reported. | Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
|
|
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| Secondary | Apparent Volume of Distribution (Vz/F) of Raltegravir | Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent volume of distribution of raltegravir during the terminal phase (Vz/F) was reported. | Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
If publication activity is not directed by the Sponsor, investigators agree to provide all manuscripts or abstracts to the Sponsor before submission.
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |