A Phase I Study of TS-142 in Healthy Participants (Single Doses)

Healthy Volunteer Clinical Trial

Official title:

A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Single Doses) (A Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169893
• Other study ID #: TS142-101
• Status: Completed
• Phase: Phase 1
• Start date: October 17, 2015
• Est. completion date: February 6, 2016

Study information

• Verified date: November 2019
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 6, 2016
• Est. primary completion date: February 6, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) =18.5 and <25.0 kg/m^2 at screening inspection

Exclusion Criteria:

• History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study

• History of drug and food allergy

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo (fasting)
Participants will receive placebo once in fasting condition
• Placebo (feeding)
Participants will receive placebo once after meal condition
• 1 mg of TS-142
Participants will receive 1 mg of TS-142 once in fasting condition
• 3 mg of TS-142
Participants will receive 3 mg of TS-142 once in fasting condition
• 10 mg of TS-142 (fasting)
Participants will receive 10 mg of TS-142 once in fasting condition
• 10 mg of TS-142 (feeding)
Participants will receive 10 mg of TS-142 once after meal condition
• 30 mg of TS-142
Participants will receive 30 mg of TS-142 once in fasting condition

Locations

Country	Name	City	State
Japan	The medical facility selected by Taisho Pharmaceutical Co., Ltd	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kambe D, Hasegawa S, Imadera Y, Mano Y, Matsushita I, Konno Y, Ogo H, Uchimura N, Uchiyama M. Pharmacokinetics, pharmacodynamics and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)	Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe	Day 1 up to Day 8
Primary	Area under the concentration-time curve AUC (tau)	Concentration of TS-142 and its metabolites in plasma	48 hours