Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety, tolerability and plasma
      pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral
      suspension doses at escalating dose levels in healthy participants, including elderly
      participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-915. TAK-915 is being tested to find a safe
      and well-tolerated dose. This study will look at the pharmacokinetic characteristics (how the
      drug acts throughout the body) of the drug and safety and tolerability (lab results, vital
      signs, ECG, and side effects) in healthy people (including elderly) who take TAK-915.

      The study will enroll a total of 88 patients. This study is designed to consist of 5
      different dosing schedules: single rising dose (SRD), multiple rising dose (MRD), drug-drug
      interaction (DDI), bioavailability and food effect (BA/FE), and Elderly Subject Single Dose
      (ESSD). The study population for SRD will consist of 48 participants enrolled into 6 cohorts.
      Each cohort will have 8 randomized participants, with 6 receiving a single dose of TAK-915,
      and 2 receiving matching placebo under fasted conditions. The starting dose is 30 mg. The
      dose for Cohorts 2 through 6 will be determined based on data collected from previous
      cohorts.

      The study population for MRD will consist of 32 participants enrolled into 4 cohorts. Each
      cohort will have 8 randomized participants, with 6 receiving one dose of TAK-915 on Day 1 and
      daily dosing on Days 8-14, and 2 receiving matching placebo under fasted conditions. The dose
      for each cohort in Part 2 will be determined based on data collected from completed SRD
      cohorts of the study.

      The study population for DDI will consist of 12 participants enrolled into 1 cohort. All
      participants will receive one dose of TAK-915 on Day 3 and daily dosing on Days 10-16 under
      fasted conditions. All participants will also receive a single dose of Midazolam 2 mg on Day
      1 and Day 16. The dose of TAK-915 in this cohort will be determined based on data collected
      from SRD cohorts and will be the same dose that is administered in MRD Cohort 8.

      The study population for BA/FE will consist of 12 participants enrolled into 1 cohort.
      TAK-915 will be administered in 3 single-dose regimens in a 3-way crossover design using 50
      mg oral dose treatments (Regimen A: TAK915 50 mg oral suspension formulation in fasted state;
      Regimen B: TAK-915 50 tablet formulation in fasted state; Regimen C: TAK-915 50 tablet
      formulation in fasted state). TAK-915 dosing will occur on Day 1 of each treatment period
      followed by a 14 day washout period.

      The study population for ESSD will consist of 8 elderly participants (ages 65-75 years)
      enrolled into 1 cohort. All 8 participants will receive a single dose of TAK-915 50 mg
      suspension under fasted conditions.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 70 days. Participants will make multiple visits to the
      clinic including a period of confinement to the clinic and will be contacted by telephone 12
      days after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-915 suspension; Midazolam; Placebo; TAK-915 tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TAK-915 oral suspension; Midazolam oral solution; Placebo-matching TAK-915 suspension; TAK-915 tablet
Other intervention name(s): Versed
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy