Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03565068 | A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007) | PHASE1 | COMPLETED | 75 | — | — | Jun 20, 2018 | Apr 3, 2020 | Mar 29, 2021 | 1 | United States |
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...