A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Drug combination/ 26489112
Intervention type(s): Drug
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: 26489112; Omeprazole; Tolbutamide