A drug-drug interaction study with TS-172 in healthy adult male subjects

JRCT ID: jRCT2071240112

Registered date:17/02/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Hyperphosphatemia
• Date of first enrollment: 13/03/2025
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Part A: Oral single administration of triazolam 0.25 mg at single administration phase, followed by an oral single administration of triazolam 0.25 mg and TS-172 20 mg at concomitant administration phase
Part B: Oral single administration of TS-172 20 mg at single administration phase, followed by an oral single administration of TS-172 and itoraconazole 200 mg at concomitant administration phase

Outcome(s)

• Primary Outcome: Drug concentration in plasma

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1. Japanese healthy adult males whose age is >=18 and <40 years at the time of obtaining informed consent
2. Subjects whose body mass index is >=18.5 and <25.0 at the screening test
3. 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
4. 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

Exclude criteria

1. 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
2. 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
3. Subjects who have been hospitalized with any treatment or undergone surgery within 12 weeks prior to receiving the drugs used in the study
4. Subjects with medical history of drug allergies (limited to severe symptoms such as anaphylaxis) or significant allergic predispositions (e.g., asthma that requires treatment)
5. Subjects who have used medications (including over-the-counter drugs) within 2 weeks prior to receiving the drugs used in the study

Related Information

• Primary Sponsor: Seiji Development Mita