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NCT03565068 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT03565068 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 75 participants.
The verdict
NCT03565068, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG MK-8189
- DRUG Background AAP Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2020-04-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03565068
The ClinicalTrials.gov registry entry for NCT03565068 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03565068 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03565068 about?
NCT03565068 is a clinical study titled "A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)". 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...
What is the current status of trial NCT03565068?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2018-06-20. Estimated completion is 2020-04-03.
What interventions are being tested in trial NCT03565068?
The interventions under investigation include: Placebo (DRUG), MK-8189 (DRUG), Background AAP Therapy (DRUG).
Who is sponsoring clinical trial NCT03565068?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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