NCT03742791 - Safety, Tolerability and Pharmacokinetics of 14-day Multiple Dose Titrations of TS-134 in Healthy Volunteers | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

59

Conditions

Healthy Volunteers

Interventions

TS-134DRUG

5 mg to 80 mg oral solution

PlaceboDRUG

Matched Placebo oral solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PAREXEL - Early Phase Clinical Unit-Los Angeles

Glendale, California, United States

Outcomes

Primary Outcomes

Incidence and Severity of Adverse Events

Time frame: Day 1 to Day 21

TS-134 Plasma Pharmacokinetic Profile - Cmax

Maximum plasma concentration