drugset / Trial / NCT03565068
A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)
RandomizedParallel-groupDouble-blindTreatment
Summary
This 4-panel study will evaluate the safety, tolerability, pharmacokinetics (PK) and corrected QT interval (QTc) effect of MK-8189 versus placebo, as monotherapy in healthy participants (Panel A) including those of Japanese descent, as monotherapy in participants with schizophrenia (Panel B), as add-on therapy in participants with schizophrenia (Panel C), and under an alternative dosing regimen as monotherapy in participants with schizophrenia (Panel D). Analysis of QTc effect will be exploratory. There will be no hypothesis testing in this study.
Timeline
- Start
- 2018-06-20
- Primary completion
- 2020-04-03
- Completion
- 2020-04-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-8189 | Small molecule | 24 mg | Oral |
| Subject | MK-8189 | Small molecule | 48 mg | Oral |
| Background | Aripirprazole | Unknown | — | — |
| Background | Asenapine | Other / unclassified | — | — |
| Background | Iloperidone | Small molecule | — | — |
| Background | Lurasidone | Small molecule | — | — |
| Background | Olanzapine | Small molecule | — | — |
| Background | Paliperidone | Unknown | — | — |
| Background | Quetiapine | Small molecule | — | — |
| Background | Risperidone | Other / unclassified | — | — |
| Background | Ziprasidone | Small molecule | — | — |