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

Last updated: May 13, 2025
Sponsor: Taisho Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

TS-172 and itraconazole

Triazolam and TS-172

Clinical Study ID

NCT06837142
TS172-03-05
  • Ages 18-39
  • Male
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Japanese healthy adult males whose age is >=18 and <40 years at the time ofobtaining 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 beeligible for participation in the study based on the results at the screening testand before administration of the drugs used in the study

  • Subjects who have been informed of the clinical trial, understand the details of thetrial, and give their written consent prior to participation in the trial

Exclusion

Exclusion Criteria:

  • Subjects with medical history ineligible for participation in the study such as ofrespiratory, cardiovascular, gastrointestinal, hepatic, renal, urologic, endocrine,metabolic, hematologic, immunologic, dermatologic, neurologic, or psychiatricdiseases

  • Subjects with medical history of disease (e.g., stomach or intestinal ulcers) orsurgery (e.g., gastrectomy, gastric bandage, gastric bypass) that may affect theabsorption 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 asanaphylaxis) or significant allergic predispositions (e.g., asthma that requirestreatment)

  • Subjects who have used medications (including over-the-counter drugs) within 2 weeksprior to receiving the drugs used in the study

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: TS-172 and itraconazole
Phase: 1
Study Start date:
March 11, 2025
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Taisho Pharmaceutical Co., Ltd selected site

    Tokyo,
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.