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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8189-012 | Other Identifier | Merck |
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The purpose of this study is to compare the pharmacokinetics (PK) of elpipodect in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants. This is Part 1 of the study; following review of the safety and PK data from Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done, Part 2 of the study will compare the PK of elpipodect in participants with mild hepatic impairment to healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Hepatic Impairment Participants | Experimental | Participants with hepatic impairment will receive a single dose of elpipodect 4 mg orally on Day 1. |
|
| Healthy Participants | Experimental | Healthy participants will receive a single dose of MK-8189 4 mg orally on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elpipodect | Drug | Administered at a dose of 4 mg via oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MK-8189 | AUC0-inf is a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood samples collected pre and post-dose at multiple timepoints were used to estimate AUC0-inf following MK-8189 administration. Geometric least-squares mean and confidence intervals for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values. | Pre-dose (0), 2, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose (hepatic impairment and healthy participants); 60, 84, 108 and 120 hours post-dose (hepatic impairment participants) |
| Maximum Observed Plasma Concentration (Cmax) of MK-8189 | Cmax is the maximum concentration of MK-8189 observed in plasma. Blood samples collected pre and post-dose at multiple timepoints were used to estimate Cmax following MK-8189 administration. Geometric least-squares mean and confidence intervals of Cmax were calculated using a linear fixed effects model performed on natural log-transformed values. | Pre-dose (0), 2, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose (hepatic impairment and healthy); 60, 84, 108 and 120 hours post-dose (hepatic impairment) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported. | Up to approximately 15 days |
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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 |
|---|---|---|---|---|---|---|
| ProSciento Inc. ( Site 0002) | Chula Vista | California | 91911 | United States | ||
| Clinical Pharmacology of Miami ( Site 0001) |
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As prespecified in the protocol, the safety and pharmacokinetic (PK) data from Part 1 of the study, comparing participants with moderate hepatic impairment to healthy participants, were reviewed after completion of Part 1. Per protocol, a decision was made to not conduct Part 2 of the study, comparing participants with mild hepatic impairment to healthy participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Hepatic Impairment Participants | Participants with moderate hepatic impairment received a single dose of MK-8189 4 mg orally on Day 1. |
| FG001 | Healthy Participants | Healthy participants received a single dose of MK-8189 4 mg orally on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Hepatic Impairment Participants | Participants with moderate hepatic impairment received a single dose of MK-8189 4 mg orally on Day 1. |
| BG001 | Healthy Participants | Healthy participants received a single dose of MK-8189 4 mg orally on Day 1. |
| 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 | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MK-8189 | AUC0-inf is a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood samples collected pre and post-dose at multiple timepoints were used to estimate AUC0-inf following MK-8189 administration. Geometric least-squares mean and confidence intervals for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values. | All participants who were compliant with the study procedures and have available data from at least one treatment. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | h*nmol/L | Pre-dose (0), 2, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose (hepatic impairment and healthy participants); 60, 84, 108 and 120 hours post-dose (hepatic impairment participants) |
|
Up to approximately 15 days
All participants who received at least one dose of treatment are included
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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 | Moderate Hepatic Impairment Participants | Participants with moderate hepatic impairment received a single dose of MK-8189 4 mg orally on Day 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | 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@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 | Feb 9, 2021 | Dec 5, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000729358 | MK-8189 |
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| Number of Participants Who Discontinue From the Study Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported. | Up to approximately 15 days |
| Miami |
| Florida |
| 33014 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants with moderate hepatic impairment received a single dose of MK-8189 4 mg orally on Day 1. |
| OG001 | Healthy Participants | Healthy participants received a single dose of MK-8189 4 mg orally on Day 1. |
|
|
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| Primary | Maximum Observed Plasma Concentration (Cmax) of MK-8189 | Cmax is the maximum concentration of MK-8189 observed in plasma. Blood samples collected pre and post-dose at multiple timepoints were used to estimate Cmax following MK-8189 administration. Geometric least-squares mean and confidence intervals of Cmax were calculated using a linear fixed effects model performed on natural log-transformed values. | All participants who were compliant with the study procedures and have available data from at least one treatment | Posted | Geometric Least Squares Mean | 95% Confidence Interval | nmol/L | Pre-dose (0), 2, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose (hepatic impairment and healthy); 60, 84, 108 and 120 hours post-dose (hepatic impairment) |
|
|
|
|
| Secondary | Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported. | All participants who received at least one dose of treatment | Posted | Count of Participants | Participants | Up to approximately 15 days |
|
|
|
| Secondary | Number of Participants Who Discontinue From the Study Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported. | All participants who received at least one dose of treatment | Posted | Count of Participants | Participants | Up to approximately 15 days |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 4 |
| 7 |
| EG001 | Healthy Participants | Healthy participants received a single dose of MK-8189 4 mg orally on Day 1. | 0 | 7 | 0 | 7 | 0 | 7 |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Affect lability | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 24.1 | 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