Healthy Volunteers
Conditions
Keywords
TS-134, multiple dose, titration
Brief summary
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.
Interventions
DRUGTS-134
5 mg to 80 mg oral solution
DRUGPlacebo
Matched Placebo oral solution
Sponsors
Taisho Pharmaceutical R&D Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind (Participant, Investigator)
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 | Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose | Apparent volumes of distribution following oral administration |
| Incidence and Severity of Adverse Events | Day 1 to Day 21 | — |
| TS-134 Plasma Pharmacokinetic Profile - Cmax | Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose | Maximum plasma concentration |
| TS-134 Plasma Pharmacokinetic Profile - AUC(0-tau) | Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose | Area under the plasma concentration vs time curve over a dosing interval |
| TS-134 Plasma Pharmacokinetic Profile - tmax | Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose | Time to maximum plasma concentration |
| TS-134 Plasma Pharmacokinetic Profile - t1/2 | Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose | Apparent terminal elimination half-life |
| TS-134 Plasma Pharmacokinetic Profile - CL/F | Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose | Apparent clearance following oral administration |
Countries
United States
Outcome results
None listed