Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese
Condition: Healthy
Intervention: T89 Group A; Placebo Group A; Placebo Group B; T89 Group B; Placebo Group C; T89 Group C
Intervention description: 150mg single dose on day 1; 150mg single dose; 300mg single dose; 300mg single dose; 225mg bid; 225mg bid
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: T89 Safety in Healthy Japanese population

Summary:

      The purpose of this study is to see how safe an investigational new drug (T89) is and how
      well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male and female volunteers aged between 20-55 years.

          2. First generation of Japanese, and live in the U.S.A. less than 5 years and maintained
             Japanese lifestyle.

          3. The body mass index between 18 and 30 kg/m2.

          4. Willing to not take alcoholic beverages, and caffeine- and the bromine-containing
             beverages and foods (e.g., tea, coffee, chocolate, cola, etc.) for the duration of the
             study beginning at the screening visit.

          5. ECG with no clinically significant abnormalities.

          6. No clinically significant medical history.

          7. Vital signs and laboratory tests with no clinically significant abnormalities.

          8. Volunteers had not taken any medication that would interfere with the procedures or
             interpretation of study data or compromise subject safety within 4 weeks prior to the
             first dose, per principal investigator discretion.

          9. Volunteers must understand and be willing, able and likely to comply with all study
             procedures and restrictions.

         10. Volunteers must be able to give voluntary written informed consent.

        Exclusion Criteria:

          1. History of uncontrolled, clinically significant neurologic, cardiovascular,
             haematological, pulmonary, hepatic, renal, metabolic, GI, urologic, immunologic,
             endocrine or psychiatric disease.

          2. Pregnant or nursing mother - Women of childbearing potential must have a negative
             pregnancy test, not be breast feeding and be established on a method of contraception
             that in the investigator's opinion is acceptable.

          3. Have on-going other treatment or medicine that may interfere with T89 or
             administration of similar medication within 2 weeks of entering study, per principal
             investigator discretion.

          4. Blood donor in recent 3 months.

          5. Have taken part in other clinical trials involving administration of study medications
             in the previous 1 month before participation.

          6. Excessive alcohol use (habitually consumed more than 21 units of alcohol per week or
             has a history of alcohol abuse as defined by DSM-IV-TR criteria (a unit of alcohol is
             equal to 1 ounce of hard liquor, 5 ounces of wine or 8 ounces of beer within past two
             years).

          7. History or evidence of habitual use of tobacco or nicotine containing products within
             3 months of Screening, with the exception of light smoking (up to 5 cigarettes per day
             or the equivalent)

          8. Known hypersensitivity to any of the ingredients of T89 or other relevant drug
             allergy.