- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04464239
A Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 in Healthy Participants
February 5, 2021 updated by: Taisho Pharmaceutical R&D Inc.
A Randomized, Double-blind, Placebo-controlled, Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 Administered Orally to Healthy Male and Female Participants
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78744
- PPD Phase I Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A: Cohort 1: TS-142 10 mg
Single dose of TS-142 10 mg or placebo in a fasted condition
|
TS-142 tablets
TS-142 matching placebo tablets
|
Experimental: Part A: Cohort 2: TS-142 30 mg
Single dose of TS-142 30 mg or placebo in a fasted condition.
|
TS-142 tablets
TS-142 matching placebo tablets
|
Experimental: Part B: Cohort 4: TS-142 20 mg
Daily doses of 20 mg TS-142 or placebo for 7 days before bedtime.
|
TS-142 tablets
TS-142 matching placebo tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and severity of Adverse Events
Time Frame: Part A: Day 1 to Day 10; Part B: Day 1 to Day 16
|
Part A: Day 1 to Day 10; Part B: Day 1 to Day 16
|
|
TS-142 Plasma Pharmacokinetic Profile - Cmax
Time Frame: 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
|
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
|
TS-142 Plasma Pharmacokinetic Profile - Tmax
Time Frame: 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
|
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
|
TS-142 Plasma Pharmacokinetic Profile - AUC(0-∞)
Time Frame: 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
|
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
|
TS-142 Plasma Pharmacokinetic Profile - AUC(0-last)
Time Frame: 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
|
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
|
TS-142 Plasma Pharmacokinetic Profile - AUC(0-tau)
Time Frame: 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
|
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
|
TS-142 Plasma Pharmacokinetic Profile - %AUCex
Time Frame: 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-∞)
|
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
|
TS-142 Plasma Pharmacokinetic Profile - λz
Time Frame: 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
|
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
|
TS-142 Plasma Pharmacokinetic Profile - t1/2
Time Frame: 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
|
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
|
TS-142 Plasma Pharmacokinetic Profile - CL/F
Time Frame: 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
|
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
|
TS-142 Plasma Pharmacokinetic Profile - Vd,z/F
Time Frame: 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
|
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
|
TS-142 Urine Pharmacokinetic Profile - Ae
Time Frame: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
Amount excreted in urine
|
Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
TS-142 Urine Pharmacokinetic Profile - Fe%
Time Frame: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
Percent of dose excreted in urine
|
Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
TS-142 Urine Pharmacokinetic Profile - CLr
Time Frame: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
Renal clearance
|
Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Taisho Director, Taisho Pharmaceutical R&D Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2020
Primary Completion (Actual)
January 21, 2021
Study Completion (Actual)
January 21, 2021
Study Registration Dates
First Submitted
July 6, 2020
First Submitted That Met QC Criteria
July 6, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Actual)
February 10, 2021
Last Update Submitted That Met QC Criteria
February 5, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TS142-US101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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