NCT01679028

Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese

Single- and Multiple- Dose-Escalation Study to Investigate the Safety and Tolerability of T89 in Japanese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Tasly Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	T89 Group A	150mg single dose on day 1
DRUG	Placebo Group A	150mg single dose
DRUG	Placebo Group B	300mg single dose
DRUG	T89 Group B	300mg single dose
DRUG	Placebo Group C	225mg bid
DRUG	T89 Group C	225mg bid

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-10-01
• Completion: 2013-02-01
• First posted: 2012-09-05
• Last updated: 2014-11-24
• Results posted: 2014-11-24

Locations

1 site across 1 country: United States