Bipolar I Disorder
Conditions
Brief summary
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.
Interventions
DRUGElpipodect
Oral Tablet
DRUGPlacebo
Oral Tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Meets diagnostic criteria for bipolar I disorder, manic or mixed features according to the Diagnostic and statistical manual of Mental Disorders TR (DSM-5 TR) and considered to be in a non-acute phase of their illness. * History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder. * Body mass index is 18 and 40 kg/m\^2, inclusive. * If currently taking an antipsychotic, is able to discontinue use at least 5 days prior to study start and the duration of the study.
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience One or More Adverse Events (AEs) | Up to 28 days | 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. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to 14 days | 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. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Panel A: 24 mg MK-8189 Participants received 24 mg MK-8189 once daily (QD) for 14 days. | 12 |
| Panel A: Placebo Participants received Panel A MK-8189-matching placebo QD for 14 days. | 5 |
| 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. | 13 |
| Panel C Placebo Participants received Panel C MK-8189-matching placebo QD for 14 days. | 4 |
| Total | 34 |
Baseline characteristics
| Characteristic | Panel A: 24 mg MK-8189 | Panel A: Placebo | Panel C: 8, 16, & 24 mg MK-8189 | Panel C Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 43.0 Years STANDARD_DEVIATION 11.5 | 40.8 Years STANDARD_DEVIATION 11.9 | 43.1 Years STANDARD_DEVIATION 12.6 | 51.5 Years STANDARD_DEVIATION 10 | 43.7 Years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 3 Participants | 11 Participants | 4 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 10 Participants | 1 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 3 Participants | 2 Participants | 3 Participants | 15 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 6 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 7 Participants | 1 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 5 | 0 / 13 | 0 / 13 | 0 / 13 | 0 / 1 | 0 / 4 |
| other Total, other adverse events | 9 / 12 | 4 / 5 | 1 / 13 | 4 / 13 | 6 / 13 | 0 / 1 | 1 / 4 |
| serious Total, serious adverse events | 2 / 12 | 0 / 5 | 0 / 13 | 0 / 13 | 0 / 13 | 0 / 1 | 0 / 4 |
Outcome results
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.
Time frame: Up to 14 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panel A: MK-8189 24 mg | Number of Participants Who Discontinue Study Treatment Due to an AE | 3 Participants |
| Panel A: Placebo | Number of Participants Who Discontinue Study Treatment Due to an AE | 1 Participants |
| Panel C: MK-8189 8 mg | Number of Participants Who Discontinue Study Treatment Due to an AE | 0 Participants |
| Panel C: 16 mg MK-8189 | Number of Participants Who Discontinue Study Treatment Due to an AE | 0 Participants |
| Panel C: MK-8189 24 mg | Number of Participants Who Discontinue Study Treatment Due to an AE | 0 Participants |
| Panel C: MK-8189 12 mg | Number of Participants Who Discontinue Study Treatment Due to an AE | 0 Participants |
| Panel C: Placebo | Number of Participants Who Discontinue Study Treatment Due to an AE | 0 Participants |
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.
Time frame: Up to 28 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panel A: MK-8189 24 mg | Number of Participants Who Experience One or More Adverse Events (AEs) | 9 Participants |
| Panel A: Placebo | Number of Participants Who Experience One or More Adverse Events (AEs) | 4 Participants |
| Panel C: MK-8189 8 mg | Number of Participants Who Experience One or More Adverse Events (AEs) | 1 Participants |
| Panel C: 16 mg MK-8189 | Number of Participants Who Experience One or More Adverse Events (AEs) | 4 Participants |
| Panel C: MK-8189 24 mg | Number of Participants Who Experience One or More Adverse Events (AEs) | 6 Participants |
| Panel C: MK-8189 12 mg | Number of Participants Who Experience One or More Adverse Events (AEs) | 0 Participants |
| Panel C: Placebo | Number of Participants Who Experience One or More Adverse Events (AEs) | 1 Participants |