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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

Must not have

History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia (TD)

History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures

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

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe muscle stiffness or uncontrollable movements.

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I have a seizure disorder or am on medication to prevent seizures.

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I have had cancer in the past.

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I have a history of heart rhythm or conduction problems.

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I often faint or have seizures.

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A family member has died suddenly from heart issues.

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I have not had major surgery or donated/lost significant blood in the last 4 weeks.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

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

Moxifloxacin

2013

Completed Phase 4

~3290

MK-8189

2020

Completed Phase 2

~1180