Clinical trial NCT03742791: Safety, Tolerability and Pharmacokinetics of 14-day Multiple Dose Titrations of TS-134 in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Titration Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TS-134 Administered Orally to Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: TS-134, multiple dose, titration
Lead sponsor: Taisho Pharmaceutical R&D Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-15
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and Severity of Adverse Events
timeFrame: Day 1 to Day 21
measure: TS-134 Plasma Pharmacokinetic Profile - Cmax
timeFrame: 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
measure: TS-134 Plasma Pharmacokinetic Profile - AUC(0-tau)
timeFrame: 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
measure: TS-134 Plasma Pharmacokinetic Profile - tmax
timeFrame: 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
measure: TS-134 Plasma Pharmacokinetic Profile - t1/2
timeFrame: 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
measure: TS-134 Plasma Pharmacokinetic Profile - CL/F
timeFrame: 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
measure: TS-134 Plasma Pharmacokinetic Profile - Vd/F
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: PAREXEL - Early Phase Clinical Unit-Los Angeles
state: California
Study officials:
affiliation: Taisho Pharmaceutical R&D Inc.
name: Taisho Director
role: STUDY_DIRECTOR
References: