A Study of Different Forms of TAK-994 in Healthy Adults
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      It is hoped that TAK-994 will eventually help people with a sleep condition called
      narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day,
      including falling asleep suddenly. Before then, the sponsor needs to understand how the body
      processes TAK-994.

      The main aims of the study are to learn how the body processes 4 different new forms of
      TAK-994, when taken with food and without food, compared to a standard form of TAK-994.

      At the first visit, the study doctor will check who can take part. Then the participants will
      be picked for 1 of 3 groups by chance. These groups of participants will take different new
      forms of TAK-994 and the standard form. They will take these with and without food. This will
      happen again 3 or 4 times but will take TAK-994 in a different order each time. After each
      treatment with TAK-994, the study doctors will check the amount of TAK-994 in the blood of
      the participants, over time. The study doctors will also check if the participants have any
      side effects from TAK-994.

      Participants will wait 5 or more days between each dose to allow time for TAK-994 to
      completely leave their bodies. Participants will stay in the clinic during their treatment
      with TAK-994. They will stay in the clinic for 15 days or longer. Participants who have 4
      treatments with TAK-994 will stay in the clinic for 20 days or longer.

      Then, the clinic will telephone the participants 12 days after their final treatment of
      TAK-994 to check if they have any health problems.
    

Detailed description: 
      The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy
      participants. This study will look at the relative BA of different TAK-994 test formulations
      relative to the currently used formulation (T1) and the effect of food on the test
      formulations in healthy participants.

      The study will enroll approximately 54 participants. The study consists of three parallel
      groups (Group 1, Group 2, and Group 3). In each group, one test TAK-994 formulation (T2
      formulations in Group 1; T3 formulations in Group 2; and T4 and T5 formulations in Group 3)
      will be evaluated under fed and fasting condition compared to reference T1 formulation under
      fasting conditions in a cross-over design. Participants will be randomly assigned into 6
      sequences within each group.

      This multi-center trial will be conducted in United States. The overall time to participate
      in this study is approximately 57 days. Participants will be followed up for up to 14 days
      after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-994; TAK-994; TAK-994; TAK-994; TAK-994
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): T2 formulation.; T1 formulation.; T3 formulation.; T4 formulation.; T5 formulation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy