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MK-8189 for Schizophrenia (TQT Trial)
Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 14 hours postdose; day 2: predose, 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, 72 hours postdose
Awards & highlights
TQT Trial Summary
This trial studies the safety and effects of a drug on the QTc interval for people with schizophrenia.
Who is the study for?
This trial is for adults with stable schizophrenia or schizoaffective disorder who have previously tolerated antipsychotic medication. It's not for those with certain mental health conditions, a history of cancer, major heart issues, blood donation or surgery within the last month, hepatitis B/C, HIV, or risk factors for Torsades de Pointes.Check my eligibility
What is being tested?
The study tests if a high dose (80 mg) of MK-8189 affects heart rhythm (QTc interval) in people with schizophrenia and checks its safety. Participants will receive either MK-8189, Moxifloxacin as a comparison drug to assess QT effects, or placebo once daily.See study design
What are the potential side effects?
Potential side effects include changes in heart rhythm and other unspecified reactions related to MK-8189. The study specifically monitors the QTc interval due to concerns about possible prolongation which can be serious.
TQT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 14 hours postdose; day 2: predose, 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, 72 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 14 hours postdose; day 2: predose, 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, 72 hours postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in QT interval corrected for heart rate (QTc) following MK-8189 treatment
Number of participants who discontinue study drug due to an AE
Number of participants with adverse events (AEs)
Secondary outcome measures
Apparent Terminal Half-life (t1/2) of MK-8189
Area Under the Plasma Concentration-Time Curve from Time 0 to last quantifiable concentration (AUC0-last) of MK-8189
Area Under the Plasma Concentration-Time curve From Time 0 to 24 hours (AUC0-24) of MK-8189
+4 moreTQT Trial Design
6Treatment groups
Experimental Treatment
Group I: Sequence 6: Placebo (Treatment C) →Moxifloxacin (Treatment B) → MK-8189 (Treatment A)Experimental Treatment3 Interventions
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 MK-8189 administered orally at 48 mg on Day 1 and 80 mg on Day 2.
Group II: Sequence 5: MK-8189 (Treatment A) →Placebo (Treatment C) →Moxifloxacin (Treatment B)Experimental Treatment3 Interventions
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 MK-8189 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.
Group III: Sequence 4: Moxifloxacin (Treatment B) → MK-8189 (Treatment A) → Placebo (Treatment C)Experimental Treatment3 Interventions
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 MK-8189 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.
Group IV: Sequence 3: Placebo (Treatment C) →MK-8189 (Treatment A) →Moxifloxacin (Treatment B)Experimental Treatment3 Interventions
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 MK-8189 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.
Group V: Sequence 2: Moxifloxacin (Treatment B) →Placebo (Treatment C) →MK-8189 (Treatment A)Experimental Treatment3 Interventions
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 MK-8189 administered orally at 48 mg on Day 1 and 80 mg on Day 2.
Group VI: Sequence 1: MK-8189 (Treatment A)→Moxifloxacin (Treatment B)→Placebo (Treatment C)Experimental Treatment3 Interventions
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 MK-8189 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-8189
2020
Completed Phase 2
~640
Moxifloxacin
2013
Completed Phase 4
~3290
Placebo
1995
Completed Phase 3
~2670
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Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,061,039 Total Patients Enrolled
23 Trials studying Schizophrenia
2,579 Patients Enrolled for Schizophrenia
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,064,297 Total Patients Enrolled
28 Trials studying Schizophrenia
4,231 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a seizure disorder or am on medication to prevent seizures.I have taken and tolerated antipsychotic medication for schizophrenia.A family member has died suddenly from heart issues.I have had severe muscle stiffness or uncontrollable movements.I often faint or have seizures.I have a history of heart issues or family history of long QT syndrome.I have had cancer in the past.You have a history of intellectual disability, borderline personality disorder, anxiety disorder, or a brain disorder.My illness is currently stable and not in an acute phase.I have not had major surgery or donated/lost significant blood in the last 4 weeks.You have been diagnosed with schizophrenia or schizoaffective disorder based on specific guidelines used by doctors.I have a history of heart rhythm or conduction problems.My chronic condition, like diabetes or high blood pressure, is under control.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence 5: MK-8189 (Treatment A) →Placebo (Treatment C) →Moxifloxacin (Treatment B)
- Group 2: Sequence 3: Placebo (Treatment C) →MK-8189 (Treatment A) →Moxifloxacin (Treatment B)
- Group 3: Sequence 4: Moxifloxacin (Treatment B) → MK-8189 (Treatment A) → Placebo (Treatment C)
- Group 4: Sequence 1: MK-8189 (Treatment A)→Moxifloxacin (Treatment B)→Placebo (Treatment C)
- Group 5: Sequence 2: Moxifloxacin (Treatment B) →Placebo (Treatment C) →MK-8189 (Treatment A)
- Group 6: Sequence 6: Placebo (Treatment C) →Moxifloxacin (Treatment B) → MK-8189 (Treatment A)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the study protocol permit individuals over sixty years of age to participate?
"To be enrolled in this research trial, participants must be between 18 and 60 years of age."
Answered by AI
What is the approximate sample size of participants in this research trial?
"Affirmative, according to the information hosted on clinicaltrials.gov this investigation is still actively recruiting individuals for participation. Initially posted on June 26th 2023 and edited most recently on July 11th of that same year, 84 people are required in total from one medical centre."
Answered by AI
Has Moxifloxacin been certified by the FDA?
"The available clinical evidence is limited, so the safety of Moxifloxacin only earned a score of 1."
Answered by AI
Can new participants still join this clinical trial?
"This clinical trial continues to admit patients, as per the latest information posted on clinicaltrials.gov. The study was originally opened for recruitment on June 26th 2023 and most recently updated on July 11th 2023."
Answered by AI
What demographic is most suitable for participating in this clinical trial?
"For this clinical trial, 84 individuals aged between 18 and 60 with a diagnosis of schizophrenia or schizoaffective disorder according to the DSM-5 criteria must be recruited. Furthermore, applicants should have prior experience taking antipsychotic medications within recommended doses and any existing comorbidities such as hypothyroidism, diabetes, hypertension etc must remain stable during recruitment."
Answered by AI
What purpose does this research endeavor seek to achieve?
"This clinical trial's primary outcome, which will be evaluated between Baseline and up to 3 days after treatment, is the Number of participants with adverse events (AEs). The secondary objectives are Change from baseline in QT interval corrected for heart rate (QTc) post-moxifloxacin administration - Electrocardiogram data obtained through a digital Holter device will determine the Fridericia correction of the QT interval (QTcF), Maximum Concentration (Cmax) of MK-8189 as assessed by pre-dose and post-dose plasma concentrations, and Time to maximum concentration (Tmax"
Answered by AI
Who else is applying?
What site did they apply to?
Velocity Clinical Research, Hallandale Beach ( Site 0002)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
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