Drug-drug Interaction Study with TS-142 in Healthy Adult Subjects (concomitant Administration of Itraconazole)

NCT ID: NCT04557163

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-13
• Study Completion Date: 2020-11-14

Brief Summary

This is an open-label, single-center, single-sequence study to evaluate the concomitant effects of the potent CYP3A inhibitor itraconazole on the single-dose pharmakokinetics, safety and tolerability of oral TS-142 in healthy subjects.

Conditions

Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects receiving TS-142 and itraconazole

Eligible subjects will receive a single dose of 5 mg TS-142 on Day 1. Subjects will also receive twice-a-day of 200 mg itraconazole on Day 3 and an once-daily single dose of 200 mg itraconazole from Day 4 to Day 7 and single dose of 1 mg TS-142 on Day 6.

Group Type: EXPERIMENTAL

TS-142

Intervention Type: DRUG

TS-142 will be given as 1 mg per capsule administered orally with water.

Itraconazole

Intervention Type: DRUG

Itraconazole will given as 50 mg per capsule administered orally with water.

Interventions

TS-142

TS-142 will be given as 1 mg per capsule administered orally with water.

Intervention Type: DRUG

Itraconazole

Itraconazole will given as 50 mg per capsule administered orally with water.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Japanese male age 20 to 39 years at the signing of informed consent
• Subjects whose body mass index (BMI) within the range 18.5 - 25.0 kg/m2, exclusive of 25.0
• Subjects who judged by the principal investigator(s) or subinvestigator(s) to be appropriate as a subjects of this study based on the results of screening tests and the tests obtained prior to the administration of the investigational drug. (Those who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test and the test obtained prior to administration of the investigational drug, and whose clinical test results are within the standard values of the clinical trial site. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator(s) or subinvestigator(s).)
• Subjects who understand, and have willingness and ability to read and sign, the informed consent form

Exclusion Criteria

• Subjects who have any disease and are judged not to be healthy based on the medical viewpoints by the principal investigator(s) or subinvestigator(s)
• Subjects who have an inappropriate history for participation in this study, including hepatic, renal, cardiovascular, hematological, endocrinological, metabolic, respiratory, gastrointestinal, dermatological, neurological, urological, immunological, psychiatric abnormalities or diseases
• Subjects who have any history of drug or food allergies

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taisho Director

Role: STUDY_DIRECTOR

Taisho Pharmaceutical Co., Ltd.

Locations

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, , Japan

Countries

Japan

Other Identifiers

TS-142-205-01

Identifier Type: -

Identifier Source: org_study_id