Schizophrenia
Conditions
Brief summary
The primary purpose of this study is to assess the safety and tolerability of multiple ascending doses of elpipodect in participants with schizophrenia.
Interventions
DRUGElpipodect
MK-8189 4 mg and/or 12 mg tablet(s) will be administered orally QD for a total daily dose of 48 mg, 60 mg, 80 mg.
DRUGPlacebo
MK-8189 dose-matching placebo tablets will be administered orally QD.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
The main inclusion and
Exclusion criteria
include but are not limited to the following: Inclusion Criteria: * Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria with the onset of the first episode being no less than 2 years prior to screening and monotherapy with antipsychotics for treatment should be indicated. * Is in the non-acute phase of their illness and clinically stable for 3 months prior to screening as demonstrated by: 1) no clinically significant change in dose of prescribed antipsychotic medication, or clinically significant change in antipsychotic medication to treat symptoms of schizophrenia for two months prior to screening; 2) no increase in level of psychiatric care due to worsening of symptoms of schizophrenia for three months prior to screening. * Has a history of receiving and tolerating antipsychotic medication within the usual dose range employed for schizophrenia. * Is able to discontinue the use of all antipsychotic medication at least 5 days or 3 half-lives (whichever is longer) prior to Day -1 and during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | Up to approximately 17 days | 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 experienced one or more AEs were reported. |
| Number of Participants Who Discontinue From Study Treatment Due to an AE | Up to approximately 3 days | 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 discontinued study due to an AE were reported. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Participant flow
Pre-assignment details
Fifty-three schizophrenia participants randomized to either MK-8189 or placebo in Panels A, A-1, and C. MK-8189 dose and schedule were modified for participants based on saftey and tolerability.
Participants by arm
| Arm | Count |
|---|---|
| Panel A MK-8189 48-60 mg Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1 and 60 mg QD on Day 2. | 8 |
| Panel A Placebo Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2. | 3 |
| Panel A-1 MK-8189 48-80 mg Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD starting on Day 1 and 80 mg QD on Day 2. | 8 |
| Panel A-1 Placebo Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD on Day 1 and Day 2. | 2 |
| Panel C MK-8189 48-80 mg Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2 and 80 mg QD on Day 3 based on participant safety and tolerability. | 18 |
| Panel C MK-8189 48 mg Participants with Schizophrenia received monotherapy MK-8189 oral dose of 48 mg QD on Days 1-2. | 2 |
| Panel C Placebo Participants with Schizophrenia received MK-8189-matching placebo oral dose of 0 mg QD Days 1-3. | 12 |
| Total | 53 |
Baseline characteristics
| Characteristic | Panel C MK-8189 48 mg | Panel C Placebo | Total | Panel A MK-8189 48-60 mg | Panel A Placebo | Panel A-1 MK-8189 48-80 mg | Panel A-1 Placebo | Panel C MK-8189 48-80 mg |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 47.0 Years STANDARD_DEVIATION 0 | 46.1 Years STANDARD_DEVIATION 8.1 | 44.6 Years STANDARD_DEVIATION 8.3 | 47.1 Years STANDARD_DEVIATION 9.2 | 42.0 Years STANDARD_DEVIATION 4 | 47.5 Years STANDARD_DEVIATION 9.7 | 36.0 Years STANDARD_DEVIATION 4.2 | 42.4 Years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 8 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 9 Participants | 45 Participants | 7 Participants | 3 Participants | 6 Participants | 2 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 39 Participants | 7 Participants | 3 Participants | 6 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 3 Participants | 7 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 20 Participants | 4 Participants | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 8 Participants | 33 Participants | 4 Participants | 2 Participants | 4 Participants | 2 Participants | 13 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 | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 8 | 0 / 8 | 0 / 2 | 0 / 20 | 0 / 20 | 0 / 12 |
| other Total, other adverse events | 3 / 8 | 2 / 8 | 0 / 3 | 3 / 8 | 4 / 8 | 0 / 2 | 7 / 20 | 6 / 18 | 6 / 12 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 8 | 0 / 8 | 0 / 2 | 0 / 20 | 0 / 18 | 0 / 12 |
Outcome results
Primary
Number of Participants Experiencing an Adverse Event (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 experienced one or more AEs were reported.
Time frame: Up to approximately 17 days
Population: All participants who received as least one dose of the investigational drug. Per protocol, safety was assessed by dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panel A MK-8189 48 mg | Number of Participants Experiencing an Adverse Event (AE) | 3 Participants |
| Panel A MK-8189 60mg | Number of Participants Experiencing an Adverse Event (AE) | 2 Participants |
| Panel A Placebo | Number of Participants Experiencing an Adverse Event (AE) | 0 Participants |
| Panel A-1 MK-8189 48 mg | Number of Participants Experiencing an Adverse Event (AE) | 3 Participants |
| Panel A-1 MK-8189 80 mg | Number of Participants Experiencing an Adverse Event (AE) | 4 Participants |
| Panel A-1 Placebo | Number of Participants Experiencing an Adverse Event (AE) | 0 Participants |
| Panel C MK-8189 48 mg | Number of Participants Experiencing an Adverse Event (AE) | 7 Participants |
| Panel C MK-8189 80 mg | Number of Participants Experiencing an Adverse Event (AE) | 6 Participants |
| Panel C Placebo | Number of Participants Experiencing an Adverse Event (AE) | 6 Participants |
Primary
Number of Participants Who Discontinue From Study Treatment 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 discontinued study due to an AE were reported.
Time frame: Up to approximately 3 days
Population: All participants who received as least one dose of the investigational drug. Per protocol, safety was assessed by dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panel A MK-8189 48 mg | Number of Participants Who Discontinue From Study Treatment Due to an AE | 0 Participants |
| Panel A MK-8189 60mg | Number of Participants Who Discontinue From Study Treatment Due to an AE | 0 Participants |
| Panel A Placebo | Number of Participants Who Discontinue From Study Treatment Due to an AE | 0 Participants |
| Panel A-1 MK-8189 48 mg | Number of Participants Who Discontinue From Study Treatment Due to an AE | 0 Participants |
| Panel A-1 MK-8189 80 mg | Number of Participants Who Discontinue From Study Treatment Due to an AE | 0 Participants |
| Panel A-1 Placebo | Number of Participants Who Discontinue From Study Treatment Due to an AE | 0 Participants |
| Panel C MK-8189 48 mg | Number of Participants Who Discontinue From Study Treatment Due to an AE | 1 Participants |
| Panel C MK-8189 80 mg | Number of Participants Who Discontinue From Study Treatment Due to an AE | 0 Participants |
| Panel C Placebo | Number of Participants Who Discontinue From Study Treatment Due to an AE | 0 Participants |