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A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy Volunteers

Healthy Clinical Trial

Official title:
An Open-Label Study to Assess the Effect of Multiple-Dose JNJ26489112 on the Cytochrome P450 Enzymes Using a 3-Probe Substrate Drug Combination in Healthy Subjects

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01147887
Study type Interventional
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status Completed
Phase Phase 1
Start date June 2010
Completion date August 2010
View Details
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