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

Taisho Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Healthy Volunteer

Treatments: Drug: Step 2: Placebo; Drug: Step 2: TS-142; Drug: Step 1: TS-142

Study type: Interventional

Funder types: Industry

Identifiers

NCT04087707

TS142-202

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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23 participants in 3 patient groups, including a placebo group

Step 1;TS-142

Experimental group

Treatment:

Drug: Step 1: TS-142

Step 2;TS-142

Experimental group

Treatment:

Drug: Step 2: TS-142

Drug: Step 2: Placebo

Step 2;Placebo

Placebo Comparator group

Treatment:

Drug: Step 2: TS-142

Drug: Step 2: Placebo