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| ID | Type | Description | Link |
|---|---|---|---|
| 26489112MDD1002 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
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The purpose of this study is to evaluate the effect of 26489112 on the pharmacokinetics (blood levels) of a combination of 3 drugs administered to healthy volunteers.
26489112 is a drug that is being tested to see if it may be useful for a number of indications including major depression. This study will compare the effects of 26489112 administered to healthy volunteers alone or in combination with a mixture of 3 drugs consisting of midazolam (a drug used for reducing anxiety or producing drowsiness or anesthesia before certain medical procedures or surgery), omeprazole (a drug used to treat symptoms of gastroesophageal reflux disease (GERD) or other conditions caused by excess stomach acid), and tolbutamide (a drug used for treating type 2 diabetes mellitus in patients when blood sugar cannot be controlled by diet and exercise alone). Approximately 20 healthy adult volunteers will be enrolled and will be treated with study drug for 22 days. Volunteers will be required to stay overnight at the study center to receive study treatment for 4 nights at the beginning of the study and for 4 nights towards the end of the study. On all other occasions, volunteers will make daily visits to the study center to receive treatment with study drug. Participants will take a combination of 3 drugs (omeprazole 20 mg capsule, tolbutamide 500 mg tablet, and midazolam 2mg/mL liquid) orally (by mouth) or 2 tablets of study drug (2648911) orally with 1 cup of water. Blood samples will be collected from study participants at protocol-specified times during the study to determine the concentration of each of the 4 drugs (26489112, midazolam, omeprazole, and tolbutamide) present in plasma (the colorless fluid portion of blood). In addition, a blood sample will be obtained from all enrolled patients before study drug administration for pharmacogenomics research (research to help identify genetic markers of response, to explain variability in the data, or to address emerging clinical issues). The primary outcome measure is the concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters at protocol-specified time points on Days 1-4 and Dasy 19-22. Safety will be monitored during the study. Healthy volunteers will receive study drug (26489112) orally (by mouth) in the morning from Day 4 through Day 21.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | Drug combination/ 26489112 On Day 1 and on Day 19 a single oral dose of a drug combination consisting of midazolam (2 mg/mL liquid) tolbutamide (a 500 mg tablet) and omeprazole (a 20 mg capsule) will be taken and on Day 4 through Day 21 a single oral dose of two 26489112 tablets will be taken. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug combination/ 26489112 | Drug | On Day 1 and on Day 19, a single, oral dose of a drug combination consisting of midazolam (2 mg/mL liquid), tolbutamide (a 500 mg tablet), and omeprazole (a 20 mg capsule) will be taken and on Day 4 through Day 21, a single oral dose of two 26489112 tablets will be taken. |
| Measure | Description | Time Frame |
|---|---|---|
| The concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters | Days 1-4 and Days 19-22 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with adverse events as a measure of safety. | From screening to the end of the study (Day 22) or at the time of early withdrawal from the study | |
| Results from clinical laboratory tests including blood glucose levels as a measure of safety. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| ID | Term |
|---|---|
| D004338 | Drug Combinations |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| From screening to the end of the study (Day 22) or at the time of early withdrawal from the study |
| Findings from ECGs and vital sign measurements as a measure of safety. | From screening to the end of the study (Day 22) or at the time of early withdrawal from the study |
| Findings from physical and neurologic examinations performed as a measure of safety. | From screening to the end of the study (Day 22) or at the time of early withdrawal from the study |