Safety, Pharmacokinetic, and Pharmacodynamic Study of TS-142 in Healthy Subjects

Healthy Volunteer Clinical Trial

Official title:

A Clinical Pharmacological Study of TS-142 in Non-Elderly and Elderly Healthy Participants (A Repeated-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Elderly and Non-Elderly Participants)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087707
• Other study ID #: TS142-202
• Status: Completed
• Phase: Phase 2
• Start date: September 17, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: December 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, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly and elderly participants

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Body mass index (BMI) =18.5 and <25.0 kg/m^2 and body weight is more than 40.0 kg at screening inspection

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant

• History of drug and food allergy

• Other protocol defined exclusion criteria could apply

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Step 1: TS-142
Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
• Step 2: TS-142
Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
• Step 2: Placebo
Elderly participants will receive placebo once daily for 7 consective days

Locations

Country	Name	City	State
Japan	Sumida Hospital	Sumida-ku	Tokyo

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 14
Primary	Area under the concentration-time curve AUC (tau)	Concentration of TS-142 and its metabolites in plasma	Day 1 up to Day 9
Primary	Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS)	Step2; as a measure of subjective alertness which is scored by 10 cm-VAS scale ranging from 1, extremely alert, to 9, extremely sleepy at the next morning after administration.	Day 1 up to Day 8