Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8189 · 1 trial · 1 indication
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, safety was analyzed by panel and dose. The number of participants who experienced one or more AEs was reported.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, safety was analyzed by panel and dose. The number of participants who discontinued study treatment due to an AE was reported.
| Arm | Type | Description |
|---|---|---|
| Panel A (Healthy Participants): MK-8189 Monotherapy 4-24 mg | EXPERIMENTAL | Healthy participants will receive MK-8189 monotherapy orally once daily (QD) in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg, depending on safety and tolerability. |
| Panel A (Healthy Participants): Placebo Monotherapy | PLACEBO_COMPARATOR | Healthy participants will receive MK-8189 monotherapy matching placebo orally QD on Days 1-18. |
| Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4-24 mg | EXPERIMENTAL | Participants with Schizophrenia will receive MK-8189 monotherapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg, depending on safety and tolerability. |
| Panel B (Schizophrenia Participants): Placebo Monotherapy | PLACEBO_COMPARATOR | Participants with Schizophrenia will receive MK-8189 monotherapy matching placebo orally QD on Days 1-18. |
| Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-24 mg | EXPERIMENTAL | In addition to background atypical antipsychotic (AAP) treatment, participants with Schizophrenia will receive MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg, depending on safety and tolerability. |
| Panel C (Schizophrenia Participants): Placebo Add-on Therapy | PLACEBO_COMPARATOR | In addition to background AAP treatment, participants with Schizophrenia will receive MK-8189 add-on therapy matching placebo orally QD on Days 1-18. |
| Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8-48 mg | EXPERIMENTAL | Participants with Schizophrenia will receive MK-8189 monotherapy orally QD in escalating doses from 8 mg to 48 mg, as follows: Days 1-3: 8 mg, Days 4-6: 16 mg, Days 7-9: 24 mg, Days 10-12: 36 mg, Days 13-15: 48 mg, depending on safety and tolerability. |
| Panel D (Schizophrenia Participants): Placebo Monotherapy | PLACEBO_COMPARATOR | Participants with Schizophrenia will receive MK-8189 monotherapy matching placebo orally QD on Days 1-15. |
| Name | Type | Description |
|---|---|---|
| MK-8189 | DRUG | MK-8189 4 mg tablet(s) will be administered orally QD for a total daily dose of 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 36 mg or 48 mg. |
| Placebo | DRUG | MK-8189 dose-matching placebo tablets will be administered orally QD. |
| Background AAP Therapy | DRUG | Participants with schizophrenia in Panel C will be on background therapy with an AAP medication (e.g., olanzapine, quetiapine, paliperidone, asenapine, iloperidone, aripirprazole, lurasidone, risperidone \[not to exceed daily dose of 6 mg\], or ziprasidone) throughout the study. Participants should be on a stable and well tolerated treatment regimen for at least 2 months prior to screening. NOTE: clozapine is not allowed. |
Inclusion Criteria Panel A (Healthy Participants) \- If participant is of Japanese descent, both biological parents and all biological grandparents must be born in Japan. Panels B and D (Participants with Schizophrenia; MK-8189 or Placebo Monotherapy / 15-Day Titration Monotherapy) - Is able to d...
MK-8189 is an investigational small molecule being developed for the treatment of schizophrenia. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to evaluate its safety, tolerability, and pharmacokinetics in participants with schizophrenia and in healthy participants.
The molecular target of MK-8189 has not been disclosed in the available information. As a small molecule in Phase 1 development for schizophrenia, its specific mechanism of action is not publicly detailed. The ongoing clinical trial focuses on safety, tolerability, and pharmacokinetics rather than target engagement.
MK-8189 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical research on this investigational drug for the treatment of schizophrenia.
MK-8189 is in Phase 1 of clinical development. It is an investigational drug and has not received regulatory approval. The completed Phase 1 trial assessed safety, tolerability, and pharmacokinetics in participants with schizophrenia and in healthy participants, with a total enrollment of 75 individuals.
MK-8189 has one completed clinical trial registered as NCT03565068, titled "A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)." This Phase 1 study was conducted in the United States, enrolled 75 participants, and was randomized, double-blind, and placebo-controlled.
MK-8189 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for schizophrenia. The completed Phase 1 trial (NCT03565068) evaluated safety, tolerability, and pharmacokinetics, but the drug has not yet progressed through the later phases required for regulatory approval.