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

NCT04557163 | Completed Phase 1

• 1 other identifier: TS-142-205-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cmax

  Maximum observed concentration of unchanged form of TS-142 and its metabolite in plasma.

  Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.

Secondary Outcomes (1)

• AUC(0-last)

  Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.

Other Outcomes (7)

• AUC(0-infinity)

  Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.

• Tmax

  Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.

• T1/2

  Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.

Study Arms (1)

Subjects receiving TS-142 and itraconazole

EXPERIMENTAL

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.

Drug: TS-142; Drug: Itraconazole

Interventions

TS-142 DRUG

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

Subjects receiving TS-142 and itraconazole

Itraconazole DRUG

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

Subjects receiving TS-142 and itraconazole

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

TS-142; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 21, 2020
• Study Start: October 13, 2020
• Primary Completion: November 14, 2020
• Study Completion: November 14, 2020
• Last Updated: February 28, 2025

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)