Safety, Tolerability and Pharmacokinetics of 14-day Multiple Dose Titrations of TS-134 in Healthy Volunteers
- Registration Number
- NCT03742791
- Lead Sponsor
- Taisho Pharmaceutical R&D Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Healthy adult subjects will be prospectively assigned to 1 of 6 cohorts. Within each cohort, 10 subjects per cohort will be randomized in a 4:1 ratio (8 active + 2 placebo) to receive daily doses of TS-134 or placebo for 14 days in a fed state, with ascending titrated dose levels ranging from 5 mg to 80 mg, depending on the assigned cohort. The maximum daily dose shall not exceed 80 mg. TS-134 TS-134 Healthy adult subjects will be prospectively assigned to 1 of 6 cohorts. Within each cohort, 10 subjects per cohort will be randomized in a 4:1 ratio (8 active + 2 placebo) to receive daily doses of TS-134 or placebo for 14 days in a fed state, with ascending titrated dose levels ranging from 5 mg to 80 mg, depending on the assigned cohort. The maximum daily dose shall not exceed 80 mg.
- Primary Outcome Measures
Name Time Method 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
Incidence and Severity of Adverse Events Day 1 to Day 21 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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PAREXEL - Early Phase Clinical Unit-Los Angeles
🇺🇸Glendale, California, United States