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Completed

NCT Number: NCT04464239

A Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 in Healthy 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase I unit

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TS-142

Drug

TS-142 tablets

TS-142 Placebo

Drug

TS-142 matching placebo tablets

Primary outcomes

  1. Incidence and severity of Adverse Events

    Time frame: Part A: Day 1 to Day 10; Part B: Day 1 to Day 16

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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-∞)

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical R&D Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2020
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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