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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8189-020 | Other Identifier | MSD |
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The goal of this study is to evaluate the safety and tolerability of elpipodect in participants with stable bipolar I disorder. There was no hypothesis testing in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: 24 mg Elpipodect | Experimental | Participants received 24 mg elpipodect once daily (QD) for 14 days. |
|
| Panel B: 16 & 24 mg Elpipodect | Experimental | Participants received 16 mg elpipodect QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14. |
|
| Panel C: 8, 16, & 24 mg Elpipodect | Experimental | Participants received 8 mg elpipodect Day 1, 16 mg on Day 2 ,and 24 mg on QD Days 3 to 14. |
|
| Panel C: Placebo | Placebo Comparator | Participants received Panel C MK-8189-matching placebo QD for 14 days. |
|
| Panel A: Placebo | Placebo Comparator | Participants received Panel A MK-8189-matching placebo QD for 14 days. |
|
| Panel B: Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elpipodect | Drug | Oral Tablet |
|
| 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, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to 28 days |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to 14 days |
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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 |
|---|---|---|---|---|---|---|
| Woodland International Research Group-Clinical Research ( Site 0009) | Little Rock | Arkansas | 72211 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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After the safety and tolerability was reviewed from the first cohort of Panel A, a protocol amendment was written to give the option to enroll either Panel B or Panel C. Panel C was selected to be enrolled; no participants were enrolled in Panel B and no data was collected for this panel.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel A: 24 mg MK-8189 | Participants received 24 mg MK-8189 once daily (QD) for 14 days. |
| FG001 | Panel A: Placebo | Participants received Panel A MK-8189-matching placebo QD for 14 days. |
| FG002 | Panel B: 16 & 24 mg MK-8189 | Participants received 16 mg MK-8189 QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14. No participants were enrolled in Panel B. |
| FG003 | Panel B: Placebo | Participants received Panel B MK-8189 matching placebo on days 1-14. No participants were enrolled in Panel B. |
| FG004 | Panel C: 8, 16, & 24 mg MK-8189 | Participants received 8 mg MK-8189 Day 1, 16 mg on Day 2, and 24 mg on QD Days 3 to 14. |
| FG005 | Panel C Placebo | Participants received Panel C MK-8189-matching placebo QD for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No participants were enrolled in Panel B and no data was collected for this panel.
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel A: 24 mg MK-8189 | Participants received 24 mg MK-8189 once daily (QD) for 14 days. |
| BG001 | Panel A: Placebo | Participants received Panel A MK-8189-matching placebo QD for 14 days. |
| 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 | Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants who received at least one dose of treatment were included in the analysis. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. | Posted | Number | Participants | Up to 28 days |
|
Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
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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 | Panel A: MK-8189 24 mg | Participants received 24 mg of MK-8189 once daily (QD) for 14 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bipolar I disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | 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 | May 17, 2024 | Jul 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000729358 | MK-8189 |
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Participants received Panel B MK-8189-matching placebo for 14 days.
|
| Placebo | Drug | Oral Tablet |
|
| Atlanta Center for Medical Research ( Site 0001) |
| Atlanta |
| Georgia |
| 30331 |
| United States |
| Hassman Research Institute Marlton Site ( Site 0006) | Marlton | New Jersey | 08053 | United States |
| Lost to Follow-up |
|
| BG002 | Panel C: 8, 16, & 24 mg MK-8189 | Participants received 8 mg MK-8189 Day 1, 16 mg on Day 2, and 24 mg on QD Days 3 to 14. |
| BG003 | Panel C Placebo | Participants received Panel C MK-8189-matching placebo QD for 14 days. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received Panel A MK-8189-matching placebo QD for 14 days. |
| OG002 | Panel B: 16 & 24 mg MK-8189 | Participants received 16 mg MK-8189 QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14. No participants were enrolled in Panel B. |
| OG003 | Panel B: Placebo | Participants received Panel B MK-8189 matching placebo on days 1-14. No participants were enrolled in Panel B. |
| OG004 | Panel C: MK-8189 8 mg | Participants received 8 mg of MK-8189 on Day 1. |
| OG005 | Panel C: 16 mg MK-8189 | Participants received 16 mg of MK-8189 on Day 2. |
| OG006 | Panel C: MK-8189 24 mg | Participants received 24 mg of MK-8189 on Days 3 to 14. One participant received 24 mg of MK-8189 on Days 3-8 and then was titrated down to 12 mg for Days 9-14 due to an AE. |
| OG007 | Panel C: MK-8189 12 mg | Participant was down-titrated per protocol to 12 mg of MK-8189 for Days 9 through 14. |
| OG008 | Panel C: Placebo | Participants received MK-8189-matching placebo QD for up to 14 days. |
|
|
| Primary | Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants who received at least one dose of treatment were included in the analysis. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. | Posted | Number | Participants | Up to 14 days |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| 9 |
| 12 |
| EG001 | Panel A: Placebo | Participants received Panel A MK-8189-matching placebo QD for 14 days. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG002 | Panel C: MK-8189 8 mg | Participants received 8 mg of MK-8189 on Day 1. | 0 | 13 | 0 | 13 | 1 | 13 |
| EG003 | Panel C: MK-8189 16 mg | Participants received 16 mg of MK-8189 on Day 2. | 0 | 13 | 0 | 13 | 4 | 13 |
| EG004 | Panel C: MK-8189 24 mg | Participants received 24 mg of MK-8189 on Days 3 to 14. One participant received 24 mg of MK-8189 on Days 3-8 and then was titrated down to 12 mg for Days 9-14 due to an AE. | 0 | 13 | 0 | 13 | 6 | 13 |
| EG005 | Panel C: MK-8189 12 mg | Participant was down-titrated per protocol to 12 mg of MK-8189 for Days 9 through 14. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG006 | Panel C: Placebo | Participants received MK-8189-matching placebo QD for up to 14 days. | 0 | 4 | 0 | 4 | 1 | 4 |
| Homicidal ideation | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oromandibular dystonia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal 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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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
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 authorship requirements.