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

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: 10 mg of TS-142 (fasting); Drug: 10 mg of TS-142 (feeding); Drug: 1 mg of TS-142; Drug: 3 mg of TS-142; Drug: Placebo (feeding); Drug: 30 mg of TS-142; Drug: Placebo (fasting)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04169893

TS142-101

Details and patient eligibility

About

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.

Enrollment: 32 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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32 participants in 7 patient groups, including a placebo group

Arm Title: Placebo (fasting)

Placebo Comparator group

Description:

fasting

Treatment:

Drug: Placebo (fasting)

Drug: 30 mg of TS-142

Drug: 3 mg of TS-142

Drug: 1 mg of TS-142

Drug: 10 mg of TS-142 (fasting)

Placebo (feeding)

Placebo Comparator group

Description:

after meal

Treatment:

Drug: Placebo (feeding)

Drug: 10 mg of TS-142 (feeding)

TS-142, 1 mg

Experimental group

Description:

fasting

Treatment:

Drug: Placebo (fasting)

Drug: 30 mg of TS-142

Drug: 3 mg of TS-142

Drug: 10 mg of TS-142 (fasting)

TS-142, 3 mg

Experimental group

Description:

fasting

Treatment:

Drug: 30 mg of TS-142

Drug: 3 mg of TS-142

Drug: 1 mg of TS-142

Drug: 10 mg of TS-142 (fasting)

TS-142, 10 mg (fasting)

Experimental group

Description:

fasting

Treatment:

Drug: Placebo (fasting)

Drug: 30 mg of TS-142

Drug: 3 mg of TS-142

Drug: 1 mg of TS-142

Drug: 10 mg of TS-142 (feeding)

Drug: 10 mg of TS-142 (fasting)

TS-142, 10 mg (feeding)

Experimental group

Description:

after meal

Treatment:

Drug: Placebo (feeding)

Drug: 10 mg of TS-142 (feeding)

Drug: 10 mg of TS-142 (fasting)

TS-142, 30 mg

Experimental group

Description:

fasting

Treatment:

Drug: Placebo (fasting)

Drug: 30 mg of TS-142

Drug: 3 mg of TS-142

Drug: 1 mg of TS-142

Drug: 10 mg of TS-142 (fasting)