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Completed

NCT Number: NCT03742791

Safety, Tolerability and Pharmacokinetics of 14-day Multiple Dose Titrations of TS-134 in Healthy Volunteers

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.

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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

PAREXEL - Early Phase Clinical Unit-Los Angeles

Glendale, California, 91206, 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
  • 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.

Treatment and study plan

TS-134

Drug

5 mg to 80 mg oral solution

Placebo

Drug

Matched Placebo oral solution

Primary outcomes

  1. Incidence and Severity of Adverse Events

    Time frame: Day 1 to Day 21

  2. TS-134 Plasma Pharmacokinetic Profile - Cmax

    Time frame: 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

    Maximum plasma concentration

  3. TS-134 Plasma Pharmacokinetic Profile - AUC(0-tau)

    Time frame: 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

    Area under the plasma concentration vs time curve over a dosing interval

  4. TS-134 Plasma Pharmacokinetic Profile - tmax

    Time frame: 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

    Time to maximum plasma concentration

  5. TS-134 Plasma Pharmacokinetic Profile - t1/2

    Time frame: 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

    Apparent terminal elimination half-life

  6. TS-134 Plasma Pharmacokinetic Profile - CL/F

    Time frame: 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

    Apparent clearance following oral administration

  7. TS-134 Plasma Pharmacokinetic Profile - Vd/F

    Time frame: 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

    Apparent volumes of distribution following oral administration

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical R&D Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 15, 2018
Registry last updated
Nov 15, 2018

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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