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Completed

NCT Number: NCT06837142

A Drug-drug Interaction Study With TS-172 in Healthy Adult Male Subjects

An open-label, single-center, single-sequence study to evaluate the drug-drud interaction between the CYP3A substrate triazolam and TS-172 (part A) and the potent CYP3A inhibitor itraconazole and TS-172 (part B) in healthy male subjects on their pharmacokinetics, safety and tolerability

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Key information

Conditions

Healthy Male Subjects

Age range

18 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Japanese healthy adult males whose age is >=18 and <40 years at the time of obtaining informed consent
  • Subjects whose body mass index is >=18.5 and <25.0 at the screening test
  • Subjects who are judged by a principal investigator or a sub-investigator to be eligible for participation in the study based on the results at the screening test and before administration of the drugs used in the study
  • Subjects who have been informed of the clinical trial, understand the details of the trial, and give their written consent prior to participation in the trial

Exclusion criteria

  • Subjects with medical history ineligible for participation in the study such as of respiratory, cardiovascular, gastrointestinal, hepatic, renal, urologic, endocrine, metabolic, hematologic, immunologic, dermatologic, neurologic, or psychiatric diseases
  • Subjects with medical history of disease (e.g., stomach or intestinal ulcers) or surgery (e.g., gastrectomy, gastric bandage, gastric bypass) that may affect the absorption of the drugs used in the study
  • Subjects who have been hospitalized with any treatment or undergone surgery within 12 weeks prior to receiving the drugs used in the study
  • Subjects with medical history of drug allergies (limited to severe symptoms such as anaphylaxis) or significant allergic predispositions (e.g., asthma that requires treatment)
  • Subjects who have used medications (including over-the-counter drugs) within 2 weeks prior to receiving the drugs used in the study

Treatment and study plan

Triazolam and TS-172

Drug

Oral single administration of triazolam 0.25 mg at single administration phase, followed by a oral single administration of triazolam 0.25 mg and TS-172 20 mg at concomitant administration phase

TS-172 and itraconazole

Drug

Oral single administrtation of TS-172 20 mg at single administration phase, followed by a oral single administration of TS-172 and itoraconazole 200 mg at concomitant administration phase

Primary outcomes

  1. Part A: Maximum plasma concentration (Cmax) of unchanged form of triazolam

    Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after dosing

  2. Part A: Area under the concentration-time curve (AUC) from time zero to time of the last quantifiable concentration of unchanged form of triazolam in plasma

    Time frame: Up to 24 hours postdose

  3. Part A: Area under the concentration-time curve (AUC) from time zero extrapolated to infinite time of unchanged form of triazolam in plasma

    Time frame: Up to 24 hours postdose

  4. Part B: Maximum plasma concentration (Cmax) of unchanged form of TS-172 and its metabolite

    Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours after dosing

  5. Part B: Area under the concentration-time curve (AUC) from time zero to time of the last quantifiable concentration of unchanged form of TS-172 and its metabolite in plasma

    Time frame: Up to 48 hours postdose

  6. Part B: Area under the concentration-time curve (AUC) from time zero extrapolated to infinite time of unchanged form of TS-172 and its metabolite in plasma

    Time frame: Up to 48 hours postdose

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
May 15, 2025

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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