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

NCT04087707 | Completed Phase 2

• 1 other identifier: TS142-202
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• 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

• Area under the concentration-time curve AUC (tau)

  Concentration of TS-142 and its metabolites in plasma

  Day 1 up to Day 9

• 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

Study Arms (3)

Step 1;TS-142

EXPERIMENTAL

Drug: Step 1: TS-142

Step 2;TS-142

EXPERIMENTAL

Drug: Step 2: TS-142; Drug: Step 2: Placebo

Step 2;Placebo

PLACEBO COMPARATOR

Drug: Step 2: TS-142; Drug: Step 2: Placebo

Interventions

Step 1: TS-142 DRUG

Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days

Step 1;TS-142

Step 2: TS-142 DRUG

Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days

Step 2;Placebo; Step 2;TS-142

Step 2: Placebo DRUG

Elderly participants will receive placebo once daily for 7 consective days

Step 2;Placebo; Step 2;TS-142

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sumida Hospital

Sumida-ku, Tokyo, 130-0004, Japan

Location

Related 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/multiple dosing: Randomized, double-blind, placebo-controlled phase-1 studies. Basic Clin Pharmacol Toxicol. 2023 Nov;133(5):576-591. doi: 10.1111/bcpt.13930. Epub 2023 Sep 10.

  PMID: 37563858 BACKGROUND

Study Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Step1; No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 12, 2019
• Study Start: September 17, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: February 28, 2025

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)