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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03746067

Enrollment

Registered

2018-11-19

Start date

2015-08-21

Completion date

2016-01-13

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

TS-134, CSF

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.

Interventions

DRUGTS-134

5 mg, 10 mg, or 20 mg oral solution

DRUGPlacebo

Matched Placebo oral solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double-blind

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
TS-134 Plasma Pharmacokinetic Profile - Vd/F	Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose	Apparent volumes of distribution following oral administration
Incidence and severity of Adverse Events	Day 1 to Day 7	—
TS-134 Plasma Pharmacokinetic Profile - Cmax	Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose	Maximum plasma concentration
TS-134 Plasma Pharmacokinetic Profile - AUC(0-last)	Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose	Area under the concentration vs. time curve from time zero to last measurable concentration
TS-134 Plasma Pharmacokinetic Profile - tmax	Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose	Time to maximum plasma concentration
TS-134 Plasma Pharmacokinetic Profile - t1/2	Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose	Apparent terminal elimination half-life
TS-134 Plasma Pharmacokinetic Profile - CL/F	Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose	Apparent clearance following oral administration

Secondary

Measure	Time frame	Description
TS-134 CSF Pharmacokinetic Profile - AUC(0-last)	Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose	Area under the CSF concentration vs. time curve from time zero to last measurable concentration
TS-134 CSF Pharmacokinetic Profile - tmax	Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose	Time to maximum CSF concentration
TS-134 CSF Pharmacokinetic Profile - t1/2	Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose	Apparent terminal elimination half-life (CSF)
TS-134 CSF Pharmacokinetic Profile - CL/F	Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose	Apparent clearance (CSF) following oral administration
TS-134 CSF Pharmacokinetic Profile - Vd/F	Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose	Apparent volumes of distribution (CSF) following oral administration
TS-134 Cerebral Spinal Fluid (CSF) Pharmacokinetic Profile - Cmax	Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose	Maximum CSF concentration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026