A Phase I Study of TS-142 in Healthy Participants (Repeated Doses)

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: TS-142, 10 mg; Drug: TS-142, 30 mg; Drug: TS-142, 20 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04169906

TS142-102

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 participants.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: TS-142, 30 mg

Drug: TS-142, 10 mg

Drug: Placebo

Drug: TS-142, 20 mg

TS-142 10 mg

Experimental group

Treatment:

Drug: TS-142, 30 mg

Drug: TS-142, 10 mg

Drug: Placebo

Drug: TS-142, 20 mg

TS-142 20 mg

Experimental group

Treatment:

Drug: TS-142, 30 mg

Drug: TS-142, 10 mg

Drug: Placebo

Drug: TS-142, 20 mg

TS-142 30 mg

Experimental group

Treatment:

Drug: TS-142, 30 mg

Drug: TS-142, 10 mg

Drug: Placebo

Drug: TS-142, 20 mg