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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID: NCT03742791
Run by: Taisho Pharmaceutical R&D Inc.
People needed: 59
Starts: 2016-06-28
Expected to finish: 2016-12-12
Last updated by the study team: 2018-11-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

PAREXEL - Early Phase Clinical Unit-Los Angeles — Glendale, California, United States

Full record on ClinicalTrials.gov

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