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 |
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.
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
Glendale, California 91206
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