New schizophrenia drug passes early safety check
NCT ID NCT02181803
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug called MK-8189 in 55 people, including healthy volunteers and those with schizophrenia. The main goal was to see if the drug is safe and how it behaves in the body. Researchers measured drug levels and side effects, but this study did not aim to treat or cure schizophrenia.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
55 people
The number who actually took part.
- Started
-
Aug 2014
- Finished
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Apr 2015
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: INCLUSION CRITERIA FOR SCHIZOPHRENIA PARTICIPANTS * Male or non-pregnant and non-breast feeding female. If participant is male with a female partner of child-bearing potential, participant must agree to use a medically acceptable method of contraception during the trial and for 120 days after the last dose of trial drug. If their partner is pregnant, males must agree to use a condom * Body Mass Index (BMI) ≥ 18.5 and ≤ 40 kg/m\^2 * Meet diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria with the onset of the first episode being no less than 2 years prior to study entry * Be in the non-acute phase of illness and clinically stable for 3 months prior to screening * History of receiving and tolerating antipsychotic medication within the usual dose range employed for schizophrenia * Participants with hypothyroidism, diabetes, high blood pressure, chronic respiratory conditions or other mild forms of these medical conditions could be considered as candidates for study enrollment if their condition is stable and the prescribed dose and regimen of medication is stable for at least 3 months prior to screening and there are no expected changes in comedication during the study * Has a negative urinary drug screen at screening INCLUSION CRITERIA FOR HEALTHY PARTICIPANTS * Male, or non-pregnant and non-breast feeding female of Japanese or non-Japanese descent. If participant is male with a female partner of child-bearing potential, participant must agree to use a medically acceptable method of contraception during the trial and for 120 days after the last dose of trial drug. If their partner is pregnant, males must agree to use a condom * Body Mass Index (BMI) ≥ 18.5 and ≤ 35 kg/m\^2 * In good health * Nonsmoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months * Has a negative urinary drug screen at screening Exclusion Criteria: EXCLUSION CRITERIA FOR SCHIZOPHRENIA PARTICIPANTS * DSM-IV axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder within one month of screening * Has evidence or history of mental retardation, borderline personality disorder, anxiety disorder, or organic brain syndrome * History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia * Untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, gastrointestinal, psychiatric, neurologic, cardiovascular, hematological, immunological or cerebrovascular disease, malignance, allergic disease or other chronic and/or degenerative process at screening * Has a history of cancer (malignancy) with certain exceptions * Treatment with clozapine for schizophrenia or treatment with monoamine oxidase inhibitors within 3 months of screening * Received a parenteral depot antipsychotic medication within 3 months of screening * Participated in another investigational study within 4 weeks, prior to screening EXCLUSION CRITERIA FOR HEALTHY PARTICIPANTS * History of clinically significant endocrine, gastrointestinal, cardiovascular (including hypertension, angina, coronary artery disease, valvular disease, heart rate or rhythm abnormalities), hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases * Mentally or legally incapacitated * History of clinically diagnosed depression, anxiety disorder, or any history of psychiatric disorders having required drug treatment or hospitalization * History of cancer (malignancy) * Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies throughout the trial * Participated in another investigational study within 4 weeks, prior to screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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