A Phase I Study of TS-142 in Healthy Participants (Repeated Doses)
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Drug: PlaceboDrug: TS-142, 10 mgDrug: TS-142, 20 mgDrug: TS-142, 30 mg
- Registration Number
- NCT04169906
- Lead Sponsor
- Taisho Pharmaceutical Co., Ltd.
- 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 participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description TS-142 10 mg TS-142, 10 mg - TS-142 10 mg TS-142, 30 mg - Placebo TS-142, 30 mg - TS-142 10 mg TS-142, 20 mg - TS-142 20 mg TS-142, 20 mg - TS-142 30 mg TS-142, 20 mg - TS-142 20 mg Placebo - TS-142 20 mg TS-142, 10 mg - TS-142 20 mg TS-142, 30 mg - TS-142 30 mg Placebo - TS-142 10 mg Placebo - Placebo Placebo - Placebo TS-142, 10 mg - Placebo TS-142, 20 mg - TS-142 30 mg TS-142, 10 mg - TS-142 30 mg TS-142, 30 mg -
- Primary Outcome Measures
Name Time Method Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) Day 1 up to Day 14 Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe
Area under the concentration-time curve AUC (tau) Day 1 up to Day 9 Concentration of TS-142 and its metabolites in plasma
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The medical facility selected by Taisho Pharmaceutical Co., Ltd
🇯🇵Fukuoka, Japan