A Phase I Study of TS-142 in Healthy Participants (Single Doses)
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Drug: Placebo (fasting)Drug: Placebo (feeding)Drug: 1 mg of TS-142Drug: 10 mg of TS-142 (feeding)Drug: 3 mg of TS-142Drug: 10 mg of TS-142 (fasting)Drug: 30 mg of TS-142
- Registration Number
- NCT04169893
- Lead Sponsor
- Taisho Pharmaceutical Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
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 (fasting) 10 mg of TS-142 (fasting) fasting Arm Title: Placebo (fasting) 1 mg of TS-142 fasting Placebo (feeding) 10 mg of TS-142 (feeding) after meal Arm Title: Placebo (fasting) 3 mg of TS-142 fasting TS-142, 1 mg 3 mg of TS-142 fasting TS-142, 10 mg (fasting) 10 mg of TS-142 (feeding) fasting TS-142, 1 mg 10 mg of TS-142 (fasting) fasting Arm Title: Placebo (fasting) 10 mg of TS-142 (fasting) fasting TS-142, 30 mg 30 mg of TS-142 fasting TS-142, 10 mg (fasting) 3 mg of TS-142 fasting TS-142, 30 mg Placebo (fasting) fasting TS-142, 30 mg 3 mg of TS-142 fasting TS-142, 1 mg 30 mg of TS-142 fasting TS-142, 30 mg 1 mg of TS-142 fasting TS-142, 1 mg Placebo (fasting) fasting Arm Title: Placebo (fasting) Placebo (fasting) fasting Arm Title: Placebo (fasting) 30 mg of TS-142 fasting TS-142, 3 mg 1 mg of TS-142 fasting TS-142, 3 mg 3 mg of TS-142 fasting TS-142, 10 mg (fasting) Placebo (fasting) fasting TS-142, 10 mg (fasting) 1 mg of TS-142 fasting Placebo (feeding) Placebo (feeding) after meal TS-142, 3 mg 10 mg of TS-142 (fasting) fasting TS-142, 3 mg 30 mg of TS-142 fasting TS-142, 10 mg (feeding) Placebo (feeding) after meal TS-142, 10 mg (fasting) 30 mg of TS-142 fasting TS-142, 10 mg (feeding) 10 mg of TS-142 (fasting) after meal TS-142, 10 mg (feeding) 10 mg of TS-142 (feeding) after meal TS-142, 30 mg 10 mg of TS-142 (fasting) fasting
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve AUC (tau) 48 hours Concentration of TS-142 and its metabolites in plasma
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) Day 1 up to Day 8 Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The medical facility selected by Taisho Pharmaceutical Co., Ltd
🇯🇵Fukuoka, Japan