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

NCT06837142 | Completed Phase 1

• 1 other identifier: TS172-03-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (6)

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

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

• 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

  Up to 24 hours postdose

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

  Up to 24 hours postdose

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

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

• 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

  Up to 48 hours postdose

• 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

  Up to 48 hours postdose

Study Arms (2)

Triazolam and TS-172 (part A)

EXPERIMENTAL

Drug: Triazolam and TS-172

TS-172 and itraconazole (part B)

EXPERIMENTAL

Drug: TS-172 and itraconazole

Interventions

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

Triazolam and TS-172 (part A)

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

TS-172 and itraconazole (part B)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

Triazolam; Itraconazole

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: March 11, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)