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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:11/21/2018
Start Date:August 21, 2015
End Date:January 13, 2016

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A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Effects of Food on the Absorption of TS-134 Administered Orally to Healthy Male and Female Subjects

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.


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.
We found this trial at
1
site
1560 East Chevy Chase Drive
Glendale, California 91206
?
mi
from
Glendale, CA
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