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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_500 | Other Identifier | Merck Registration Number |
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This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy participants.
Study Design:
This study plans to enroll 16 participants in Part I (8 participants with moderate hepatic insufficiency and 8 healthy participants) and 16 participants in Part II (8 participants with mild hepatic insufficiency and 8 healthy participants).
Part II will be conducted only if the primary hypothesis is not met and there is a significant difference in the PK of suvorexant between healthy participants and moderate hepatic insufficiency participants in Part I.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Moderate Hepatic Insufficiency (Part I) | Experimental | Participants with moderate hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part I of the study. |
|
| Healthy Participants (Part I) | Experimental | Healthy participants matched to participants with moderate hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part I of the study. |
|
| Participants with Mild Hepatic Insufficiency (Part II) | Experimental | Participants with mild hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part II of the study (if conducted). |
|
| Healthy Participants (Part II) | Experimental | Healthy participants matched to participants with mild hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part II of the study (if conducted). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug | single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Moderate Hepatic Insufficiency Participants Versus Healthy Participants (Part I) | Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
| AUC(0-∞) After Single Dose Suvorexant: Mild Hepatic Insufficiency Participants Versus Healthy Participants (Part II) | Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Suvorexant After Single Dose: Moderate Hepatic Insufficiency Participants Versus Healthy Participants | Cmax was defined as the maximum observed concentration of a drug after administration. | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
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Inclusion Criteria for Hepatic Insufficiency Participants:
Inclusion Criteria for Healthy Matched Participants:
Exclusion Criteria for Hepatic Insufficiency Participants:
months
respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma
Exclusion Criteria for Healthy Matched Participants:
cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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16 participants were enrolled in Part I of the study. Because the primary hypothesis was met, no participants were enrolled in Part II of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Moderate Hepatic Insufficiency (Part I) | Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant. |
| FG001 | Healthy Participants (Part I) | Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant. |
| FG002 | Participants With Mild Hepatic Insufficiency (Part II) | Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm. |
| FG003 | Healthy Participants (Part II) | Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics were only presented for participants in Part I of the study (N=16). No participants were enrolled in Part II of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Moderate Hepatic Insufficiency (Part I) | Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant. |
| BG001 | Healthy Participants (Part I) |
| 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 Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Moderate Hepatic Insufficiency Participants Versus Healthy Participants (Part I) | Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant. | All Treated Participants | Posted | Geometric Mean | 95% Confidence Interval | μM•hr | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
|
AEs were collected from the time of study drug administration up to approximately 14 days post study drug administration.
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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 | Participants With Moderate Hepatic Insufficiency (Part I) | Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 |
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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 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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|
| Number of Participants With an Adverse Event (AE) |
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. |
| From administration of study drug through 14 days after administration of study drug |
| Number of Participants Who Discontinued Study Due to an AE | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. | From administration of study drug through 14 days after administration of study drug |
Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Healthy Participants (Part I) | Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant. |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Suvorexant After Single Dose: Moderate Hepatic Insufficiency Participants Versus Healthy Participants | Cmax was defined as the maximum observed concentration of a drug after administration. | All Treated Participants | Posted | Geometric Mean | 95% Confidence Interval | μM | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
|
|
|
|
| Primary | AUC(0-∞) After Single Dose Suvorexant: Mild Hepatic Insufficiency Participants Versus Healthy Participants (Part II) | Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant. | Per protocol, the decision to perform AUC(0-∞) analysis in mild hepatic insufficiency participants was conditional on results of AUC(0-∞) analysis in moderate hepatic insufficiency participants. Since the primary hypothesis in moderate hepatic insufficiency participants was met, AUC(0-∞) analysis in mild hepatic insufficiency was not done. | Posted | Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
|
|
| Secondary | Number of Participants With an Adverse Event (AE) | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. | All Treated Participants | Posted | Number | participants | From administration of study drug through 14 days after administration of study drug |
|
|
|
| Secondary | Number of Participants Who Discontinued Study Due to an AE | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. | All Treated Participants | Posted | Number | participants | From administration of study drug through 14 days after administration of study drug |
|
|
|
| 0 |
| 8 |
| 7 |
| 8 |
| EG001 | Healthy Participants (Part I) | Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant. | 0 | 8 | 5 | 8 |
| Fatigue | General disorders | MedDRA 14.0 |
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| Somnolence | Nervous system disorders | MedDRA 14.0 |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
| D001523 |
| Mental Disorders |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |