Healthy Volunteers
Conditions
Keywords
TS-142
Brief summary
This is a study to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of TS-142 compared to placebo and of a single repeated dose compared to placebo in healthy volunteers. This Phase I study is composed of two parts; Part A (Single Ascending Dose) and Part B (Repeated Dose). The study employs a randomized, double-blind, placebo-controlled, parallel group design to evaluate the single and repeat-dose safety and pharmacokinetics of TS-142 in healthy participants.
Interventions
DRUGTS-142
TS-142 tablets
DRUGTS-142 Placebo
TS-142 matching placebo tablets
Sponsors
Taisho Pharmaceutical R&D Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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, inclusive * Body weight ≥ 45 kg at screening and admission visits. * Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m\^2 at screening visit.
Exclusion criteria
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and/or admission visits. * Clinically significant abnormal physical examination (including neurological assessments), vital signs, or 12-lead ECGs at the screening and/or admission visits. * QTcF \>450 msec for male participants or QTcF \>470 msec for female participants at the screening and/or admission visits. * Significant history or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, neurological, immunologic, ophthalmologic, metabolic or oncological disease. * History or present diagnosis of sleep disorders. * Currently experiencing sleep disturbance related to postmenopausal symptoms at the screening and/or admission visits. * History or presence of suicidal behavior, defined as participants who have answered 'YES' to any of the C-SSRS suicidal behavior questions at the screening and/or admission visits. * Positive urine screen for alcohol or controlled substances at the screening or admission visits. * Recent history (within the previous 6 months) of alcohol or drug abuse. * Regular alcohol consumption of \> 2 units/day or 10 units/week during the last 3 months prior to screening. One unit is equivalent to 8 g of alcohol: a half pint (240 mL) of beer, a glass (125 mL) of wine, or 25 mL of spirits. * Current use, or use of tobacco or tobacco-containing products (cigarettes, pipes, e-cigarettes, nicotine patches, etc.) during the month prior to screening, or positive urine cotinine screen (\>400 ng/mL) at the screening and/or admission visits. * History of and/or current evidence of serologic positive results for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV) antibodies 1 and 2. * Donation of one or more units of blood, plasma (including platelet donations), or acute loss of an equivalent amount of blood within 60 days prior to screening visit (one unit= 450 mL). * Exposure to any investigational product within 60 days prior to screening. * Use of any prescription or over-the-counter medication, herbal medication, vitamins, or mineral supplements within 14 days prior to administration of the study drug. * Participants who regularly consume \>500 mg of caffeine on a daily basis. * Is known to be allergic to the study drug or any components of the study drug. * Participated in strenuous exercise within 48 hours prior to study start (initial dosing) and/or is unwilling to avoid strenuous exercise at any time throughout the study. * Participants who work night shifts or need to work night shifts during the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of Adverse Events | Part A: Day 1 to Day 10; Part B: Day 1 to Day 16 | — |
| TS-142 Plasma Pharmacokinetic Profile - Cmax | Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose | Maximum plasma concentration |
| TS-142 Plasma Pharmacokinetic Profile - Tmax | Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose | Time to maximum plasma concentration |
| TS-142 Plasma Pharmacokinetic Profile - AUC(0-∞) | Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose | Area Under the Concentration vs. Time Curve from Time Zero to Infinity |
| TS-142 Plasma Pharmacokinetic Profile - AUC(0-last) | Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose | Area Under the Concentration vs. Time Curve from Time Zero to Last Measurable Concentration |
| TS-142 Plasma Pharmacokinetic Profile - AUC(0-tau) | Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose | Area Under the Concentration vs. Time Curve over a Dosing Interval |
| TS-142 Plasma Pharmacokinetic Profile - %AUCex | Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose | Percentage of the area extrapolated for calculation of AUC(0-∞) |
| TS-142 Plasma Pharmacokinetic Profile - λz | Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose | Elimination rate constant |
| TS-142 Plasma Pharmacokinetic Profile - t1/2 | Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose | Apparent terminal half-life |
| TS-142 Plasma Pharmacokinetic Profile - CL/F | Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose | Apparent oral clearance |
| TS-142 Plasma Pharmacokinetic Profile - Vd,z/F | Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose | Volumes of distribution |
| TS-142 Urine Pharmacokinetic Profile - Ae | Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose | Amount excreted in urine |
| TS-142 Urine Pharmacokinetic Profile - Fe% | Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose | Percent of dose excreted in urine |
| TS-142 Urine Pharmacokinetic Profile - CLr | Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose | Renal clearance |
Countries
United States
Outcome results
None listed