Conditions: Healthy
Keywords: T89 Safety in Healthy Japanese population
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: yes

Brief 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.

Detailed description:
This is a single centre, double-blind, randomized, placebo controlled, single- and multiple- dose-escalation study.

After informed consent is obtained, subjects were evaluated with a medical history questionnaire, physical examination, blood and urine collections for clinical laboratory safety tests, urine drug screen, serum pregnancy test for each women, vital signs and ECG. The subjects who fulfill the inclusion criteria but no exclusion criteria were provisionally enrolled. For participation in this trial, subjects were instructed to avoid any prescription, over-the-counter (OTC), and alternative / complementary medications or significant changes in diet without advance permission from principal investigator. The subjects were instructed to discontinue alcohol, caffeine and bromine containing beverage/food. 20 subjects were enrolled and divided into three Groups: Group A, Group B and Group C.

Arms:
arm 1: 150mg Placebo Single dose arm 2: 150mg T89 single dose arm 3: 300mg placebo single dose arm 4: 300mg T89 single dose arm 5: 225mg Placebo bid for 14 days arm 6: 225mg T89 bid for 14 days

Interventions: intervention 1: T89 Group A intervention 2: Placebo Group A intervention 3: Placebo Group B intervention 4: T89 Group B intervention 5: Placebo Group C intervention 6: T89 Group C
Intervention descriptions: intervention 1: 150mg single dose on day 1 intervention 2: 150mg single dose intervention 3: 300mg single dose intervention 4: 300mg single dose intervention 5: 225mg bid intervention 6: 225mg bid

Protocol document: