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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8189-019 | Other Identifier | Merck |
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The primary purpose of this study to evaluate the effect of a supratherapeutic dose of 80 mg elpipodect on the QT interval corrected for heart rate (QTc interval) and to assess the safety and tolerability of multiple once-daily doses of elpipodect in participants with schizophrenia. The effects of 3 treatment sequences 1) elpipodect (48 mg [Day 1] and 80 mg [Day2]); 2) standard image placebo (Day 1) and moxifloxacin 400 mg (Day 2); and 3) elpipodect placebo (Day 1 and Day 2) were assessed with 5-day washout intervening sequence. Participants received all treatments in a counter-balanced order according to 1 of 6 possible treatment sequences.
The primary hypothesis is that the administration of an 80 mg elpipodect dose on Day 2 does not prolong the QTc interval to a clinically significant degree. Specifically, the true mean difference (elpipodect - placebo) in QTc change from baseline is less than 10 milliseconds (msec).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Elpipodect (Treatment A)→Moxifloxacin (Treatment B)→Placebo (Treatment C) | Experimental | Participants receive a sequence of Treatment A in Period 1 followed by Treatment B in Period 2 followed by Treatment C in Period 3; there will be a 5-day washout between periods. Treatment A consists of elpipodect administered orally at 48 mg on Day 1 and 80 mg on day 2. Treatment B consists of placebo administered orally on Day 1 and moxifloxacin administered orally at 400 mg on Day 2. Treatment C consists of placebo administered orally on Day 1 and Day 2. |
|
| Sequence 2: Moxifloxacin (Treatment B) →Placebo (Treatment C) →Elpipodect (Treatment A) | Experimental | Participants receive a sequence of Treatment B in Period 1 followed by Treatment C in Period 2 followed by Treatment A in Period 3; there will be a 5-day washout between periods. Treatment B consists of placebo administered orally on Day 1 and moxifloxacin administered orally at 400 mg on Day 2. Treatment C consists of placebo administered orally on Day 1 and Day 2. Treatment A consists of elpipodect administered orally at 48 mg on Day 1 and 80 mg on Day 2. |
|
| Sequence 3: Placebo (Treatment C) →Elpipodect (Treatment A) →Moxifloxacin (Treatment B) | Experimental | Participants receive a sequence of Treatment C in Period 1 followed by Treatment A in in Period 2 followed by Treatment B in Period 3; there will be a 5-day washout between periods. Treatment C consists of placebo administered orally on Day 1 and Day 2. Treatment A consists of elpipodect administered orally at 48 mg on Day 1 and 80 mg on Day 2. Treatment B consists of placebo administered orally on Day 1 and moxifloxacin administered orally at 400 mg on Day 2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elpipodect | Drug | Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment | Electrocardiogram data was obtained using a digital Holter device and the Fridericia correction of the QT interval (QTcF) was determined. The change from baseline in QTcF (ΔQTcF [msec]) was calculated by subtracting the QTcF value at the timepoint from the QTcF baseline value. Negative values represent a decrease from baseline and vice versa. An average of up to 9 predose ECGs on Day 1 served as baseline to compare postdose effects. Per protocol, the primary endpoint compares MK-8189 to placebo. | Day 1 (MK-8189 48 mg and placebo) and Day 2 (MK-8189 80 mg and placebo) |
| Number of Participants With 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 ~30 days after each dose |
| Number of Participants Discontinuing Study Therapy Due to 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 ~30 days after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment | Electrocardiogram data was obtained using a digital Holter device and the Fridericia correction of the QT interval (QTcF) was determined. The change from baseline in QTcF (ΔQTcF [msec]) was calculated by subtracting the QTcF value at the timepoint from the QTcF baseline value. Negative values represent a decrease from baseline and vice versa. An average of up to 9 predose ECGs on Day 1 served as baseline to compare postdose effects. Per protocol, the secondary endpoint compares moxifloxacin to placebo on Day 2. Moxifloxacin was tested for statistical significance 1 to 4 hours postdose (ie, around moxifloxacin Cmax) to ensure assay sensitivity. Hochberg's step-up method was applied to preserve the overall α level at .05 for the hypothesis testing. |
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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 |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0003) | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Treatments were administered in a counterbalanced manner on Day 1 and Day 2 of each of 3 treatment periods. Periods 1 and 2 were separated by 5-day washout. 'A' refers to MK-8189 48 mg (Day 1) and 80 mg (Day 2); 'B' refers to Standard Image Placebo (Day 1) and Moxifloxacin 400 mg (Day 2); and 'C' refers to placebo to MK-8189 (Days 1 and 2).
Participants with stable schizophrenia or schizoaffective disorder were enrolled at 4 study sites in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A/B/C | Participants received treatment sequence A/B/C. |
| FG001 | Sequence A/C/B | Participants received treatment sequence A/C/B. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 16, 2023 |
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|
| Sequence 4: Moxifloxacin (Treatment B) →Elpipodect (Treatment A) → Placebo (Treatment C) | Experimental | Participants receive a sequence of Treatment B in Period 1 followed by Treatment A in Period 2 followed by Treatment C in Period 3; there will be a 5-day washout between periods. Treatment B consists of placebo administered orally on Day 1 and moxifloxacin administered orally at 400 mg on Day 2. Treatment A consists of elpipodect administered orally at 48 mg on Day 1 and 80 mg on Day 2. Treatment C consists of placebo administered orally on Day 1 and Day 2. |
|
| Sequence 5: Elpipodect (Treatment A) →Placebo (Treatment C) →Moxifloxacin (Treatment B) | Experimental | Participants receive a sequence of Treatment A in Period 1 followed by Treatment C in Period 2 followed by Treatment B in Period 3; there will be a 5-day washout between periods. Treatment A consists of elpipodect administered orally at 48 mg on Day 1 and 80 mg on Day 2. Treatment C consists of placebo administered orally on Day 1 and Day 2. Treatment B consists of placebo administered orally on Day 1 and moxifloxacin administered orally at 400 mg on Day 2. |
|
| Sequence 6: Placebo (Treatment C) →Moxifloxacin (Treatment B) → Elpipodect (Treatment A) | Experimental | Participants receive a sequence of Treatment C in Period 1 followed by Treatment B in Period 2 followed by Treatment A in Period 3; there will be a 5-day washout between periods. Treatment C consists of placebo administered orally on Day 1 and Day 2. Treatment B consists of placebo administered orally on Day 1 and moxifloxacin administered orally at 400 mg on Day 2. Treatment A consists of elpipodect administered orally at 48 mg on Day 1 and 80 mg on Day 2. |
|
|
| Moxifloxacin | Drug | Oral Tablet |
|
| Placebo | Drug | Oral Tablet |
|
| Day 2 |
| Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of MK-8189 | AUC0-24 is defined as the area under concentration-time curve from 0 to 24 hours postdose. Blood samples taken at pre-dose and up to 24 hours post-dose will be used to determine the AUC0-24 of MK-8189. | Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24 hours postdose |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-8189 | AUC0-last is defined as the area under concentration-time curve from 0 to 24 hours. Blood samples taken at pre-dose and up to 72 hours post-dose will be used to extrapolate the AUC0-last of MK-8189. | Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, and 72 hours postdose |
| Maximum Concentration (Cmax) of MK-8189 | Cmax is the maximum plasma concentration of MK-8189. | Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, 72 hours postdose |
| Concentration of MK-8189 at 24 Hours (C24) Post-dose | C24 is the plasma concentration 24 hours postdose. | Day 1 and Day 2: 24 hours postdose |
| Apparent Terminal Half-life (t½) of MK-8189 | t½ is the time required for the Cmax plasma concentration to reduce by 50%. Per protocol, t½ was determined only for MK-8189 80 mg. | Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, 72 hours postdose |
| Time to Maximum Concentration (Tmax) of MK-8189 | Tmax is defined as the time to reach Cmax. | Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, and 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, and 72 hours postdose |
| NRC Research Institute ( Site 0004) | Orange | California | 92868 | United States |
| Velocity Clinical Research, Hallandale Beach ( Site 0002) | Hallandale | Florida | 33009 | United States |
| Hassman Research Institute Marlton Site ( Site 0001) | Marlton | New Jersey | 08053 | United States |
| FG002 | Sequence B/A/C | Participants received treatment sequence B/A/C. |
| FG003 | Sequence B/C/A | Participants received treatment sequence B/C/A. |
| FG004 | Sequence C/A/B | Participants received treatment sequence C/A/B. |
| FG005 | Sequence C/B/A | Participants received treatment sequence C/B/A. |
| Treatment Period 1 + 5 Day Washout |
|
| Treatment Period 2 + 5 Day Washout |
|
| Treatment Period 3 |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A/B/C | Participants received treatment sequence A/B/C. |
| BG001 | Sequence ACB | Participants received treatment sequence A/C/B. |
| BG002 | Sequence B/A/C | Participants received treatment sequence B/A/C. |
| BG003 | Sequence B/C/A | Participants received treatment sequence B/C/A. |
| BG004 | Sequence C/A/B | Participants received treatment sequence C/A/B. |
| BG005 | Sequence C/B/A | Participants received treatment sequence C/B/A. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment | Electrocardiogram data was obtained using a digital Holter device and the Fridericia correction of the QT interval (QTcF) was determined. The change from baseline in QTcF (ΔQTcF [msec]) was calculated by subtracting the QTcF value at the timepoint from the QTcF baseline value. Negative values represent a decrease from baseline and vice versa. An average of up to 9 predose ECGs on Day 1 served as baseline to compare postdose effects. Per protocol, the secondary endpoint compares moxifloxacin to placebo on Day 2. Moxifloxacin was tested for statistical significance 1 to 4 hours postdose (ie, around moxifloxacin Cmax) to ensure assay sensitivity. Hochberg's step-up method was applied to preserve the overall α level at .05 for the hypothesis testing. | All participants who received ≥1 dose of moxifloxacin, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included. | Posted | Mean | 95% Confidence Interval | ΔQTcF (msec) | Day 2 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of MK-8189 | AUC0-24 is defined as the area under concentration-time curve from 0 to 24 hours postdose. Blood samples taken at pre-dose and up to 24 hours post-dose will be used to determine the AUC0-24 of MK-8189. | All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nM | Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24 hours postdose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-8189 | AUC0-last is defined as the area under concentration-time curve from 0 to 24 hours. Blood samples taken at pre-dose and up to 72 hours post-dose will be used to extrapolate the AUC0-last of MK-8189. | All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nM | Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, and 72 hours postdose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment | Electrocardiogram data was obtained using a digital Holter device and the Fridericia correction of the QT interval (QTcF) was determined. The change from baseline in QTcF (ΔQTcF [msec]) was calculated by subtracting the QTcF value at the timepoint from the QTcF baseline value. Negative values represent a decrease from baseline and vice versa. An average of up to 9 predose ECGs on Day 1 served as baseline to compare postdose effects. Per protocol, the primary endpoint compares MK-8189 to placebo. | All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included. | Posted | Mean | 95% Confidence Interval | ΔQTcF (msec) | Day 1 (MK-8189 48 mg and placebo) and Day 2 (MK-8189 80 mg and placebo) |
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| Primary | Number of Participants With 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 treated participants are included. | Posted | Count of Participants | Participants | Up to ~30 days after each dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) of MK-8189 | Cmax is the maximum plasma concentration of MK-8189. | All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, 72 hours postdose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Concentration of MK-8189 at 24 Hours (C24) Post-dose | C24 is the plasma concentration 24 hours postdose. | All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | Day 1 and Day 2: 24 hours postdose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Half-life (t½) of MK-8189 | t½ is the time required for the Cmax plasma concentration to reduce by 50%. Per protocol, t½ was determined only for MK-8189 80 mg. | All participants who received MK-8189 80 mg, had sufficient terminal phase data, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, 72 hours postdose |
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| Secondary | Time to Maximum Concentration (Tmax) of MK-8189 | Tmax is defined as the time to reach Cmax. | All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included. | Posted | Median | Full Range | hours | Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, and 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, and 72 hours postdose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Discontinuing Study Therapy Due to 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 treated participants are included. | Posted | Count of Participants | Participants | Up to ~30 days after each dose |
|
Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-8189 48 mg | Participants received a single dose of MK-8189 48 mg on Day 1. | 0 | 98 | 1 | 98 | 24 | 98 |
| EG001 | MK-8189 80 mg | Participants received a single dose of MK-8189 80 mg on Day 2. | 0 | 92 | 0 | 92 | 21 | 92 |
| EG002 | MK-8189 Placebo | Participants received placebo on Day 1 and Day 2. | 0 | 90 | 1 | 90 | 15 | 90 |
| EG003 | Standard Image Placebo Day 1 | Participants received a single dose of standard image placebo on Day 1. | 0 | 89 | 0 | 89 | 7 | 89 |
| EG004 | Moxifloxacin 400 mg Day 2 | Participants received a single dose of moxifloxacin 400 mg on Day 2. | 0 | 89 | 0 | 89 | 11 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Excessive eye blinking | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Application site injury | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Feeling of body temperature change | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Medical device site irritation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Withdrawal Syndrome | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Orthostatic heart rate response increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oromandibular dystonia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment | For standard image placebo event was presyncope (not syncope) |
|
| Tardive dyskinesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bruxism | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Schizoprenia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hallucinations auditory | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular 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. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Feb 19, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729358 | MK-8189 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
|
| 0.5 hr (Day 1 only) |
|
|
| 1 hr |
|
|
| 2 hr |
|
|
| 3 hr |
|
|
| 4 hr |
|
|
| 8 hr |
|
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| 11 hr |
|
|
| 14 hr |
|
|
| 16 hr |
|
|
| 24 hr |
|
|
| 0.0141 |
| LS Mean Difference |
| 8.44 |
| 2-Sided |
| 90 |
| 6.31 |
| 10.56 |
| Other |
LS Mean Difference 2 Hr |
| t-test, 1 sided | <0.0001 | LS Mean Difference | 10.80 | 2-Sided | 90 | 8.85 | 12.74 | Other | LS Mean Difference 3 Hr |
| t-test, 1 sided | 0.1045 | LS Mean Difference | 6.43 | 2-Sided | 90 | 3.96 | 8.91 | Other | LS Mean Difference Week 4 Hr |
| LS Mean Difference | 6.52 | 2-Sided | 90 | 4.66 | 8.38 | Other | LS Mean Difference 8 Hr |
| LS Mean Difference | 7.33 | 90 | 4.74 | 9.93 | Other | LS Mean Difference 11 Hr |
| LS Mean Difference | 6.42 | 2-Sided | 90 | 3.95 | 8.88 | Other | LS Mean Difference 14 Hr |
| LS Mean Difference | 2.79 | 2-Sided | 90 | 0.81 | 4.76 | Other | LS Mean Difference 24 Hr |
Participants received a single dose of placebo. |
| OG004 | Standard Image Placebo Day 1 | Participants received a single dose of placebo. |
| OG005 | Moxifloxacin 400 mg Day 2 | Participants received a single dose of moxifloxacin 400 mg. |
|
|
Participants received a single dose of placebo. |
| OG004 | Standard Image Placebo Day 1 | Participants received a single dose of placebo. |
| OG005 | Moxifloxacin 400 mg Day 2 | Participants received a single dose of moxifloxacin 400 mg. |
|
|
| OG003 | Placebo Day 2 | Participants received a single dose of placebo. |
| OG004 | Standard Image Placebo Day 1 | Participants received a single dose of standard image placebo on Day 1. |
| OG005 | Moxifloxacin 400 mg Day 2 | Participants received a single dose of moxifloxacin 400 mg on Day 2. |
|
|
|
Participants received a single dose of moxifloxacin 400 mg. |
|
|
| OG004 |
| Standard Image Placebo Day 1 |
Participants received a single dose of placebo. |
| OG005 | Moxifloxacin 400 mg Day 2 | Participants received a single dose of moxifloxacin 400 mg. |
|
|
Participants received a single dose of moxifloxacin 400 mg. |
| OG005 | Standard Image Placebo Day 1 | Participants received a single dose of placebo. |
|
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|
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| Units | Counts |
|---|---|
| Participants |
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Participants received a single dose of moxifloxacin 400 mg. |
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