A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the concentration of 31001074 in blood samples from
      healthy volunteers who have been administered 31001074 and paroxetine.
    

Detailed description: 
      This is an open-label (both volunteer and study physician will know the identity of study
      treatment) pharmacokinetic study to determine the effects, if any that multiple 20-mg doses
      of paroxetine have on the concentration of a single dose of study drug (referred to as
      31001074) in the bloodstream after paroxetine and 31001074 are administered orally (by mouth)
      to healthy adult volunteers. Paroxetine is an approved drug used to treat patients with
      psychiatric disorders and 31001074 is a drug that is currently under development for
      potential uses in the treatment of patients with nervous system disorders. Approximately 14
      healthy volunteers will participate in the study for approximately 45 days (includes a
      screening period of up to 29 days to determine eligibility and a 16 day treatment period).
      Volunteers will be required to stay overnight at the study center during the 16-day treatment
      period. During the 16-day treatment period, volunteers will receive 2 doses of 31001074 and
      12 doses of paroxetine. At Screening, a blood sample will be collected from all volunteers
      for pharmacogenomic analysis (ie, genetic testing) to identify volunteers
      genetically-determined to have high activity of an enzyme (CYP2D6) that is involved in the
      processing of 31001074 by the body. Additional blood samples will be obtained from volunteers
      at protocol-specified time points during the study to determine the concentration of 31001074
      and paroxetine in plasma (the colorless portion of blood). Safety will be evaluated during
      the study by monitoring adverse events (side effects) reported and findings from clinical
      laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical
      examinations performed. In addition, volunteers will be instructed to report the occurrence
      of adverse events that are considered by the study physician to be serious (as defined by the
      protocol) for up to 30 days after the administration of the last dose of study drug. A single
      dose of 31001074 will be administered on Day 1 and Day 13 (total 2 doses). Paroxetine will be
      administered once daily from Days 4 through 15 (total 12 doses). All doses, including
      31001074 and paroxetine will be administered at the same time (approximately 8 am), except on
      Day 13, when paroxetine will be administered 30 minutes (approximately 7:30 am) before the
      administration of 31001074.
    

Intervention name(s): 31001074/paroxetine
Intervention type(s): Drug
Intervention description(s): 1 tablet of 31001074 will be administered on Day 1 and Day 13. One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15
Intervention MeSH terms: Paroxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: 31001074; Paroxetine; CYP2D6 inhibitor