Safety, Tolerability and Pharmacokinetics of Single Doses of TS-134 in Healthy Volunteers

NCT ID: NCT03746067

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-21
• Study Completion Date: 2016-01-13

Brief Summary

This is a Phase 1a study involving single oral dose of TS-134 in healthy male and female subjects. The safety, tolerability and pharmacokinetics of single dose of TS-134 will be evaluated.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TS-134

Healthy adult subjects will be prospectively assigned to 1 of 4 cohorts. Within each cohort, 8 subjects will be randomized in a 3:1 ratio (6 active + 2 placebo) per cohort to receive TS-134 or placebo as a single oral dose solution. All cohorts will be dosed in a fasted state except for the 2nd and 4th (food effect) cohorts, which will be dosed first in a fasted state, and then in a fed state, in a single crossover design conducted with a washout between two periods. In the 3rd (CSF) cohort, 8 subjects will receive one dose level of TS-134 as a single-blind dosing assignment; there will be no placebo dosing.

Group Type: EXPERIMENTAL

TS-134

Intervention Type: DRUG

5 mg, 10 mg, or 20 mg oral solution

Placebo

Healthy adult subjects will be prospectively assigned to 1 of 4 cohorts. Within each cohort, 8 subjects will be randomized in a 3:1 ratio (6 active + 2 placebo) per cohort to receive TS-134 or placebo as a single oral dose solution. All cohorts will be dosed in a fasted state except for the 2nd and 4th (food effect) cohorts, which will be dosed first in a fasted state, and then in a fed state, in a single crossover design conducted with a washout between two periods. In the 3rd (CSF) cohort, the 8 subjects will receive one dose level of TS-134 as a single-blind dosing assignment; there will be no placebo dosing.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched Placebo oral solution

Interventions

TS-134

5 mg, 10 mg, or 20 mg oral solution

Intervention Type: DRUG

Placebo

Matched Placebo oral solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy adult male and female participants between 18 and 55 years of age
• Body weight greater than or equal to 45 kg
• Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m^2

Exclusion Criteria

• Female participants who are pregnant, intend to become pregnant, or are breastfeeding
• Clinically significant abnormal physical examination, 12-lead electrocardiogram (ECG) OR cardiac telemetry prior to dosing.
• Significant history or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, locomotor, immunologic, ophthalmologic, metabolic or oncological disease.
• History or presence of psychiatric or neurologic disease or condition
• History of alcohol or drug abuse
• Any participant who currently uses or has used tobacco or tobacco-containing products for at least one month prior to screening
• Participated in strenuous exercise within 48 hours prior to study start (initial dosing) and/or are unwilling to avoid strenuous exercise at any time throughout the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taisho Pharmaceutical R&D Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taisho Director

Role: STUDY_DIRECTOR

Taisho Pharmaceutical R&D Inc.

Locations

PAREXEL - Early Phase Clinical Unit-Los Angeles

Glendale, California, United States

Countries

United States

Other Identifiers

TS134-US101

Identifier Type: -

Identifier Source: org_study_id