Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-058; TAK-058 Placebo
Intervention description: TAK-058 Solution; TAK-058 placebo-matching solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      multiple doses of TAK-058 in healthy non-elderly and elderly participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages for this study are 18 to 60 years for non-elderly and 18 to 65 years for elderly.

          -  A male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for 12 weeks after last dose.

          -  A female participant with no childbearing potential, which is defined as the subject
             has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal
             ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2
             years and follicle-stimulating hormone [FSH]>40 IU/L).

          -  Weighs at least 45 kg (99 lbs) and has a body mass index (BMI) between 18.0 and 30.0
             kg/m^2, inclusive at Screening.

        Exclusion Criteria:

          -  Has received any investigational compound within 30 days prior to the first dose of
             study medication.

          -  Has received TAK-058 in a previous clinical study.

          -  Is an immediate family member, study site employee, or is in a dependent relationship
             with a study site employee who is involved in the conduct of this study (eg, spouse,
             parent, child, sibling) or may consent under duress.

          -  Has a known hypersensitivity to any component of the formulation of TAK-058.

          -  Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).

          -  Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse within 6 months prior to the Screening Visit or is unwilling to agree to abstain
             from alcohol and drugs throughout the study.

          -  Female participants of childbearing potential (premenopausal, non-sterilized), or has
             a positive pregnancy test.

          -  Male participants that intend to donate sperm during the course of this study or for
             12 weeks thereafter.

          -  Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic
             disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy,
             asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding
             in the subject's medical history, physical examination, or safety laboratory tests
             giving reasonable suspicion of a disease that would contraindicate taking TAK-058, or
             a similar drug in the same class, or that might interfere with the conduct of the
             study. This includes, but is not limited to, peptic ulcer disease, seizure disorders
             and cardiac arrhythmias.

          -  Has previously had a seizure or convulsion (lifetime), including absence seizure and
             febrile convulsion.

          -  Has current or recent (within 6 months) gastrointestinal disease that would be
             expected to influence the absorption of drugs (ie, a history of malabsorption, any
             surgical intervention known to impact absorption [eg, bariatric surgery or bowel
             resection], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent
             [more than once per week] occurrence of heartburn).

          -  Has a history of cancer or other malignancy, except basal cell carcinoma that has been
             in remission for at least 5 years prior to Day 1.

          -  Has a positive test result for hepatitis B surface antigen (HBsAg), antibody to
             hepatitis C virus (anti-HCV) or a known history of human immunodeficiency virus
             infection at Screening.

          -  Has poor peripheral venous access.

          -  Has donated or lost 450 mL or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 45 days prior to Day
             1.

          -  Has a Screening or Check-in (Day -1) abnormal (clinically significant [CS])
             electrocardiogram (ECG).

          -  Has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 60
             to 90 mm Hg for diastolic, confirmed with one repeat testing within a maximum of 5
             minutes, at the Screening Visit or Check-in (Day -1) Visit.

          -  Has a resting heart rate outside the range 50 to 100 bpm, confirmed with repeat
             testing within a maximum of 5 minutes, at the Screening Visit or Check-in (Day -1)
             Visit.

          -  Has a QT interval with Fridericia's correction method (QTcF) >450 ms (males) or >470
             ms (females) or PR outside the range of 120 to 220 ms, confirmed with one repeat
             testing within a maximum of 5 minutes, at the Screening Visit or Check-in (Day -1)
             Visit.

          -  Has abnormal Screening or Check-in (Day -1) laboratory values that suggest a CS
             underlying disease or subject with the following lab abnormalities: ALT and/or AST
             >1.5 the upper limits of normal.

          -  Has a risk of suicide according to the investigator's clinical judgment (eg, per
             Columbia-Suicide Severity Rating Scale [C-SSRS]) or has made a suicide attempt in the
             previous 6 months.

          -  Has uncontrolled, CS neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic,
             gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder,
             or other abnormality, which may impact the ability of the subject to participate or
             potentially confound the study results.

          -  Has used nicotine-containing products (including but not limited to cigarettes,
             electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum)
             within 28 days prior to Check-in (Day -1). Cotinine test is positive at Screening or
             Check-in (Day -1).