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.

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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