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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557163
• Other study ID #: TS-142-205-01
• Status: Completed
• Phase: Phase 1
• Start date: October 13, 2020
• Est. completion date: November 14, 2020

Study information

• Verified date: November 2020
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 14, 2020
• Est. primary completion date: November 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

• Other protocol defined exclusion criteria could apply

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• TS-142
TS-142 will be given as 1 mg per capsule administered orally with water.
• Itraconazole
Itraconazole will given as 50 mg per capsule administered orally with water.

Locations

Country	Name	City	State
Japan	Taisho Pharmaceutical Co., Ltd selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AUC(0-infinity)	Area under the concentration-time curve from time zero extrapolated to infinite time 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.
Other	Tmax	Time to Cmax 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.
Other	T1/2	Terminal phase half-life 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.
Other	Vz/F	Apparent Volume of Distribution During Terminal Phase 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.
Other	CL/F	Apparent Oral Clearance 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.
Other	?z	terminal elimination rate constant 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.
Other	AUC(0-24h)	Area under the concentration-time curve from time zero to time 24 h 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.
Primary	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	AUC(0-last)	Area under the concentration-time curve from time zero to time of the last quantifiable concentration 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.